<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01705496</url>
  </required_header>
  <id_info>
    <org_study_id>BVD002</org_study_id>
    <nct_id>NCT01705496</nct_id>
  </id_info>
  <brief_title>[124I]FIAU PET-CT Scanning in Patients With Pain in a Prosthetic Knee or Hip Joint</brief_title>
  <acronym>PJI</acronym>
  <official_title>Sensitivity and Specificity of [124I]FIAU PET-CT Scanning in Patients Presenting With Pain in a Prosthetic Knee or Hip Joint</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>BioMed Valley Discoveries, Inc</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>BioMed Valley Discoveries, Inc</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This protocol will evaluate the sensitivity and specificity of [124I]FIAU as a diagnostic&#xD;
      imaging agent for the detection of prosthetic joint infections in patients.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    The sensitivity and specificity were not able to be assessed in this study due to the poor&#xD;
    image quality.&#xD;
  </why_stopped>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">November 2013</completion_date>
  <primary_completion_date type="Actual">May 2013</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Estimate the Sensitivity and Specificity of [124I]FIAU</measure>
    <time_frame>30 hours</time_frame>
    <description>The sensitivity and specificity of [124I]FIAU in the detection of prosthetic joint infection was determined based on the correlation of the patient's infection status determined by an independent image reviewer and the infection status assessed by an adjudication committee.&#xD;
Presence or absence of infection: Images were to be assessed and optimized on an ongoing basis. The single blinded reader was to assess independently the PET-CT images (attenuation corrected [AC] and non-AC PET plus the AC CT) and provide a diagnosis (infected or uninfected) using the chosen parameter(s) without knowing the results of the surgery. The radiology reviewer was not given any additional clinical information on the patient for reassessments relative to the initial reads. A separate central radiologist was to read the comparator X-rays independently for the presence or absence of infection. All pathology slides were to be read by a single pathologist. Local microbiology results were to be used.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Evaluate the Safety and Tolerability of [124I]FIAU</measure>
    <time_frame>30 +/- 2 days</time_frame>
    <description>Safety will be monitored throughout the study for all subjects. safety will be assessed by monitoring of adverse events,vital signs,physical exams, and clinical laboratory tests including CBC, serum chemistry.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Define PET-CT Interpretation Criteria That Best Differentiate Infected vs Non-infected Prosthetic Joints</measure>
    <time_frame>30 +/- 2 days</time_frame>
    <description>The efficacy of [124I]FIAU could not be established due to the non-specific nature of the PET-CT signals caused by the metal artifacts from the prosthesis and pronounced muscle uptake of FIAU. It was impossible to define image review parameters for diagnosis of prosthetic joint infection.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Understand the Prevalence of Prosthetic Joint Infection</measure>
    <time_frame>30 +/- 2 days</time_frame>
    <description>The trial failed primary outcome, and this secondary outcome was not analyzed</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Explore Whether the Adjudication Committee Evaluation of a Subject's Infection Status Correlates With Either of the Two Proposed Published Standards</measure>
    <time_frame>30 +/- 2 days</time_frame>
    <description>An independent adjudication committee will assess the totality of clinical information from each subject and assign them a status of infected or uninfected. The subject's infection status will be compared with either of the two proposed published standards to determine whether it corelates with any of the current consensus definitions or diagnostic algorithms.&#xD;
The trial failed primary outcome, and this secondary outcome was not analyzed.</description>
  </other_outcome>
  <other_outcome>
    <measure>Estimate the Sensitivity and Specificity of Plain X-ray in Detecting Prosthetic Joint Infection</measure>
    <time_frame>15 mins</time_frame>
    <description>The adjudication committee evaluation of a subject's infection status will be used as the standard of truth to which X-ray is compared.&#xD;
The trial failed primary outcome, and this secondary outcome was not analyzed.</description>
  </other_outcome>
  <other_outcome>
    <measure>Determine the Sensitivity and Specificity of [124I]FIAU vs. Plain X-ray in Detecting Prosthetic Joint Infection</measure>
    <time_frame>30 hours</time_frame>
    <description>The adjudication committee evaluation of a subject's infection status will be used as the standard of truth to which [124I]FIAU and X-ray are compared.&#xD;
The trial failed primary outcome, and this secondary outcome was not analyzed.</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">23</enrollment>
  <condition>Prosthetic Joint Infections</condition>
  <arm_group>
    <arm_group_label>[124I]FIAU</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single dose study of [124I]FIAU in patients presenting with pain in a prosthetic knee or hip joint who will undergo PET-CT scanning.</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>[124I]FIAU</intervention_name>
    <description>This is a single dose study of 5 mCi [124I]FIAU in subjects presenting with pain in a prosthetic knee or hip joint. Subject will receive two PET-CT scans after [124I]FIAU injection.</description>
    <arm_group_label>[124I]FIAU</arm_group_label>
    <other_name>Fialuridine</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Males or females age &gt;18 years&#xD;
&#xD;
          2. Ability to provide informed consent&#xD;
&#xD;
          3. A plain anterior-posterior (AP) and frog leg lateral X-ray of the hip or knee within 6&#xD;
             weeks of enrollment&#xD;
&#xD;
          4. Need for operative intervention in the opinion of the surgeon to correct the pain in&#xD;
             the prosthetic joint&#xD;
&#xD;
          5. Prosthetic joint implant that has been in site for more than 3 months prior to&#xD;
             enrolment&#xD;
&#xD;
          6. Having adequate general health to be expected to tolerate surgery adn to survive for 6&#xD;
             months from the time of informed consent&#xD;
&#xD;
          7. Women must be either postmenopausal or surgically sterile&#xD;
&#xD;
          8. Ability to return for all study assessments&#xD;
&#xD;
          9. Clinically euthyroid, or on stable thyroid replacement therapy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Subjects who are unable to comply with study requirements&#xD;
&#xD;
          2. Indication, in the opinion of the principal investigator, for urgent surgery that&#xD;
             would preclude the time needed for PET-CT scanning&#xD;
&#xD;
          3. History of an inherited mitochondrial disorder (e.g., Leber's hereditary neuropathy;&#xD;
             neuropathy; ataxia, retinitis pigmentosa and ptosis [NARP]; myoneurogenic&#xD;
             gastrointestinal encephalopathy [MNGIE]; myocolonic epilepsy with ragged red fibers&#xD;
             [MERFF]; and mitochondrial myopathy, encephalomyopathy, lactic acidosis and&#xD;
             stroke-like syndrome [MELAS])&#xD;
&#xD;
          4. Alanine aminotransferase (ALT) &gt;5x the upper limit of normal (ULN) OR aspartate&#xD;
             aminotransferase (AST) &gt;5X ULN&#xD;
&#xD;
          5. Creatinine clearance &lt;30 mL/min&#xD;
&#xD;
          6. Body mass that exceeds the rating of the CT table&#xD;
&#xD;
          7. Hypersensitivity to iodine&#xD;
&#xD;
          8. Any condition that would put the subject at reasonable risk in the opinion of the&#xD;
             investigator&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Coastal Clinical Research, Inc.</name>
      <address>
        <city>Mobile</city>
        <state>Alabama</state>
        <zip>36608</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tucson Orthopaedic Institute</name>
      <address>
        <city>Tucson</city>
        <state>Arizona</state>
        <zip>85712</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Arkansas for Medical Sciences</name>
      <address>
        <city>Little Rock</city>
        <state>Arkansas</state>
        <zip>72205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gulfcoast Research Institute, LLC</name>
      <address>
        <city>Sarasota</city>
        <state>Florida</state>
        <zip>34232</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Phoenix Clinical Research, LLC</name>
      <address>
        <city>Tamarac</city>
        <state>Florida</state>
        <zip>33321</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Washington University School of Medicine</name>
      <address>
        <city>St. Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mission Hospital</name>
      <address>
        <city>Asheville</city>
        <state>North Carolina</state>
        <zip>28801</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>OrthoCarolina Research Institute</name>
      <address>
        <city>Charlotte</city>
        <state>North Carolina</state>
        <zip>28207</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hosptial of the University of Pennsylvania</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Trials of Texas, Incorporated</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2016</verification_date>
  <study_first_submitted>October 10, 2012</study_first_submitted>
  <study_first_submitted_qc>October 10, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 12, 2012</study_first_posted>
  <results_first_submitted>January 11, 2016</results_first_submitted>
  <results_first_submitted_qc>February 8, 2016</results_first_submitted_qc>
  <results_first_posted type="Estimate">March 7, 2016</results_first_posted>
  <last_update_submitted>February 8, 2016</last_update_submitted>
  <last_update_submitted_qc>February 8, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 7, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Phase II</keyword>
  <keyword>FIAU</keyword>
  <keyword>Fialuridine</keyword>
  <keyword>Prosthetic</keyword>
  <keyword>Joint</keyword>
  <keyword>Infection</keyword>
  <keyword>PET-CT</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fialuridine</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>[124I]FIAU</title>
          <description>Single dose study of [124I]FIAU in patients presenting with pain in a prosthetic knee or hip joint who will undergo PET-CT scanning.&#xD;
[124I]FIAU: This is a single dose study of 5 mCi [124I]FIAU in subjects presenting with pain in a prosthetic knee or hip joint. Subject will receive two PET-CT scans after [124I]FIAU injection.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="23"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="19"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>[124I]FIAU</title>
          <description>Single dose study of [124I]FIAU in patients presenting with pain in a prosthetic knee or hip joint who will undergo PET-CT scanning.&#xD;
[124I]FIAU: This is a single dose study of 5 mCi [124I]FIAU in subjects presenting with pain in a prosthetic knee or hip joint. Subject will receive two PET-CT scans after [124I]FIAU injection.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="23"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="64.1" spread="9.11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Estimate the Sensitivity and Specificity of [124I]FIAU</title>
        <description>The sensitivity and specificity of [124I]FIAU in the detection of prosthetic joint infection was determined based on the correlation of the patient's infection status determined by an independent image reviewer and the infection status assessed by an adjudication committee.&#xD;
Presence or absence of infection: Images were to be assessed and optimized on an ongoing basis. The single blinded reader was to assess independently the PET-CT images (attenuation corrected [AC] and non-AC PET plus the AC CT) and provide a diagnosis (infected or uninfected) using the chosen parameter(s) without knowing the results of the surgery. The radiology reviewer was not given any additional clinical information on the patient for reassessments relative to the initial reads. A separate central radiologist was to read the comparator X-rays independently for the presence or absence of infection. All pathology slides were to be read by a single pathologist. Local microbiology results were to be used.</description>
        <time_frame>30 hours</time_frame>
        <population>Out of 23 enrolled, only 22 received the investigational drug. One subject withdrew.</population>
        <group_list>
          <group group_id="O1">
            <title>[124I]FIAU</title>
            <description>Single dose study of [124I]FIAU in patients presenting with pain in a prosthetic knee or hip joint who will undergo PET-CT scanning.&#xD;
[124I]FIAU: This is a single dose study of 5 mCi [124I]FIAU in subjects presenting with pain in a prosthetic knee or hip joint. Subject will receive two PET-CT scans after [124I]FIAU injection.</description>
          </group>
        </group_list>
        <measure>
          <title>Estimate the Sensitivity and Specificity of [124I]FIAU</title>
          <description>The sensitivity and specificity of [124I]FIAU in the detection of prosthetic joint infection was determined based on the correlation of the patient's infection status determined by an independent image reviewer and the infection status assessed by an adjudication committee.&#xD;
Presence or absence of infection: Images were to be assessed and optimized on an ongoing basis. The single blinded reader was to assess independently the PET-CT images (attenuation corrected [AC] and non-AC PET plus the AC CT) and provide a diagnosis (infected or uninfected) using the chosen parameter(s) without knowing the results of the surgery. The radiology reviewer was not given any additional clinical information on the patient for reassessments relative to the initial reads. A separate central radiologist was to read the comparator X-rays independently for the presence or absence of infection. All pathology slides were to be read by a single pathologist. Local microbiology results were to be used.</description>
          <population>Out of 23 enrolled, only 22 received the investigational drug. One subject withdrew.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>80% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="22"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="80" lower_limit="65" upper_limit="95"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Evaluate the Safety and Tolerability of [124I]FIAU</title>
        <description>Safety will be monitored throughout the study for all subjects. safety will be assessed by monitoring of adverse events,vital signs,physical exams, and clinical laboratory tests including CBC, serum chemistry.</description>
        <time_frame>30 +/- 2 days</time_frame>
        <population>22 received the investigational drug. A single IV injection of 5 mCi [124I]FIAU was well tolerated in patients presenting with pain in a prosthetic joint.</population>
        <group_list>
          <group group_id="O1">
            <title>[124I]FIAU</title>
            <description>Single dose study of [124I]FIAU in patients presenting with pain in a prosthetic knee or hip joint who will undergo PET-CT scanning.&#xD;
[124I]FIAU: This is a single dose study of 5 mCi [124I]FIAU in subjects presenting with pain in a prosthetic knee or hip joint. Subject will receive two PET-CT scans after [124I]FIAU injection.</description>
          </group>
        </group_list>
        <measure>
          <title>Evaluate the Safety and Tolerability of [124I]FIAU</title>
          <description>Safety will be monitored throughout the study for all subjects. safety will be assessed by monitoring of adverse events,vital signs,physical exams, and clinical laboratory tests including CBC, serum chemistry.</description>
          <population>22 received the investigational drug. A single IV injection of 5 mCi [124I]FIAU was well tolerated in patients presenting with pain in a prosthetic joint.</population>
          <units>participants with adverse events</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="22"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Define PET-CT Interpretation Criteria That Best Differentiate Infected vs Non-infected Prosthetic Joints</title>
        <description>The efficacy of [124I]FIAU could not be established due to the non-specific nature of the PET-CT signals caused by the metal artifacts from the prosthesis and pronounced muscle uptake of FIAU. It was impossible to define image review parameters for diagnosis of prosthetic joint infection.</description>
        <time_frame>30 +/- 2 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>[124I]FIAU</title>
            <description>Single dose study of [124I]FIAU in patients presenting with pain in a prosthetic knee or hip joint who will undergo PET-CT scanning.&#xD;
[124I]FIAU: This is a single dose study of 5 mCi [124I]FIAU in subjects presenting with pain in a prosthetic knee or hip joint. Subject will receive two PET-CT scans after [124I]FIAU injection.</description>
          </group>
        </group_list>
        <measure>
          <title>Define PET-CT Interpretation Criteria That Best Differentiate Infected vs Non-infected Prosthetic Joints</title>
          <description>The efficacy of [124I]FIAU could not be established due to the non-specific nature of the PET-CT signals caused by the metal artifacts from the prosthesis and pronounced muscle uptake of FIAU. It was impossible to define image review parameters for diagnosis of prosthetic joint infection.</description>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Understand the Prevalence of Prosthetic Joint Infection</title>
        <description>The trial failed primary outcome, and this secondary outcome was not analyzed</description>
        <time_frame>30 +/- 2 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>[124I]FIAU</title>
            <description>Single dose study of [124I]FIAU in patients presenting with pain in a prosthetic knee or hip joint who will undergo PET-CT scanning.&#xD;
[124I]FIAU: This is a single dose study of 5 mCi [124I]FIAU in subjects presenting with pain in a prosthetic knee or hip joint. Subject will receive two PET-CT scans after [124I]FIAU injection.</description>
          </group>
        </group_list>
        <measure>
          <title>Understand the Prevalence of Prosthetic Joint Infection</title>
          <description>The trial failed primary outcome, and this secondary outcome was not analyzed</description>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Explore Whether the Adjudication Committee Evaluation of a Subject's Infection Status Correlates With Either of the Two Proposed Published Standards</title>
        <description>An independent adjudication committee will assess the totality of clinical information from each subject and assign them a status of infected or uninfected. The subject's infection status will be compared with either of the two proposed published standards to determine whether it corelates with any of the current consensus definitions or diagnostic algorithms.&#xD;
The trial failed primary outcome, and this secondary outcome was not analyzed.</description>
        <time_frame>30 +/- 2 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>[124I]FIAU</title>
            <description>Single dose study of [124I]FIAU in patients presenting with pain in a prosthetic knee or hip joint who will undergo PET-CT scanning.&#xD;
[124I]FIAU: This is a single dose study of 5 mCi [124I]FIAU in subjects presenting with pain in a prosthetic knee or hip joint. Subject will receive two PET-CT scans after [124I]FIAU injection.</description>
          </group>
        </group_list>
        <measure>
          <title>Explore Whether the Adjudication Committee Evaluation of a Subject's Infection Status Correlates With Either of the Two Proposed Published Standards</title>
          <description>An independent adjudication committee will assess the totality of clinical information from each subject and assign them a status of infected or uninfected. The subject's infection status will be compared with either of the two proposed published standards to determine whether it corelates with any of the current consensus definitions or diagnostic algorithms.&#xD;
The trial failed primary outcome, and this secondary outcome was not analyzed.</description>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Estimate the Sensitivity and Specificity of Plain X-ray in Detecting Prosthetic Joint Infection</title>
        <description>The adjudication committee evaluation of a subject's infection status will be used as the standard of truth to which X-ray is compared.&#xD;
The trial failed primary outcome, and this secondary outcome was not analyzed.</description>
        <time_frame>15 mins</time_frame>
        <group_list>
          <group group_id="O1">
            <title>[124I]FIAU</title>
            <description>Single dose study of [124I]FIAU in patients presenting with pain in a prosthetic knee or hip joint who will undergo PET-CT scanning.&#xD;
[124I]FIAU: This is a single dose study of 5 mCi [124I]FIAU in subjects presenting with pain in a prosthetic knee or hip joint. Subject will receive two PET-CT scans after [124I]FIAU injection.</description>
          </group>
        </group_list>
        <measure>
          <title>Estimate the Sensitivity and Specificity of Plain X-ray in Detecting Prosthetic Joint Infection</title>
          <description>The adjudication committee evaluation of a subject's infection status will be used as the standard of truth to which X-ray is compared.&#xD;
The trial failed primary outcome, and this secondary outcome was not analyzed.</description>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Determine the Sensitivity and Specificity of [124I]FIAU vs. Plain X-ray in Detecting Prosthetic Joint Infection</title>
        <description>The adjudication committee evaluation of a subject's infection status will be used as the standard of truth to which [124I]FIAU and X-ray are compared.&#xD;
The trial failed primary outcome, and this secondary outcome was not analyzed.</description>
        <time_frame>30 hours</time_frame>
        <group_list>
          <group group_id="O1">
            <title>[124I]FIAU</title>
            <description>Single dose study of [124I]FIAU in patients presenting with pain in a prosthetic knee or hip joint who will undergo PET-CT scanning.&#xD;
[124I]FIAU: This is a single dose study of 5 mCi [124I]FIAU in subjects presenting with pain in a prosthetic knee or hip joint. Subject will receive two PET-CT scans after [124I]FIAU injection.</description>
          </group>
        </group_list>
        <measure>
          <title>Determine the Sensitivity and Specificity of [124I]FIAU vs. Plain X-ray in Detecting Prosthetic Joint Infection</title>
          <description>The adjudication committee evaluation of a subject's infection status will be used as the standard of truth to which [124I]FIAU and X-ray are compared.&#xD;
The trial failed primary outcome, and this secondary outcome was not analyzed.</description>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>[124I]FIAU</title>
          <description>Single dose study of [124I]FIAU in patients presenting with pain in a prosthetic knee or hip joint who will undergo PET-CT scanning.&#xD;
[124I]FIAU: This is a single dose study of 5 mCi [124I]FIAU in subjects presenting with pain in a prosthetic knee or hip joint. Subject will receive two PET-CT scans after [124I]FIAU injection.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Hypersensitivity to a concomitant drug</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="15" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Leukocytosis &amp; Thrombocytosis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Diarrhoea and nausea</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Injection site pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Drug hypersensitivity</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>procedural complications</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Michelle Zhang, Executive Director</name_or_title>
      <organization>Biomed valley discoveries</organization>
      <phone>7815339412</phone>
      <email>mzhang@biomed-valley.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01705496
org study id: BVD002
nct id: NCT01705496
lead sponsor: 
has dmc: No
This protocol will evaluate the sensitivity and specificity of [124I]FIAU as a diagnostic
      imaging agent for the detection of prosthetic joint infections in patients.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Estimate the Sensitivity and Specificity of [124I]FIAU
time frame: 30 hours
description: The sensitivity and specificity of [124I]FIAU in the detection of prosthetic joint infection was determined based on the correlation of the patient's infection status determined by an independent image reviewer and the infection status assessed by an adjudication committee.
Presence or absence of infection: Images were to be assessed and optimized on an ongoing basis. The single blinded reader was to assess independently the PET-CT images (attenuation corrected [AC] and non-AC PET plus the AC CT) and provide a diagnosis (infected or uninfected) using the chosen parameter(s) without knowing the results of the surgery. The radiology reviewer was not given any additional clinical information on the patient for reassessments relative to the initial reads. A separate central radiologist was to read the comparator X-rays independently for the presence or absence of infection. All pathology slides were to be read by a single pathologist. Local microbiology results were to be used.
measure: Evaluate the Safety and Tolerability of [124I]FIAU
time frame: 30 +/- 2 days
description: Safety will be monitored throughout the study for all subjects. safety will be assessed by monitoring of adverse events,vital signs,physical exams, and clinical laboratory tests including CBC, serum chemistry.
measure: Define PET-CT Interpretation Criteria That Best Differentiate Infected vs Non-infected Prosthetic Joints
time frame: 30 +/- 2 days
description: The efficacy of [124I]FIAU could not be established due to the non-specific nature of the PET-CT signals caused by the metal artifacts from the prosthesis and pronounced muscle uptake of FIAU. It was impossible to define image review parameters for diagnosis of prosthetic joint infection.
measure: Understand the Prevalence of Prosthetic Joint Infection
time frame: 30 +/- 2 days
description: The trial failed primary outcome, and this secondary outcome was not analyzed
measure: Explore Whether the Adjudication Committee Evaluation of a Subject's Infection Status Correlates With Either of the Two Proposed Published Standards
time frame: 30 +/- 2 days
description: An independent adjudication committee will assess the totality of clinical information from each subject and assign them a status of infected or uninfected. The subject's infection status will be compared with either of the two proposed published standards to determine whether it corelates with any of the current consensus definitions or diagnostic algorithms.
The trial failed primary outcome, and this secondary outcome was not analyzed.
measure: Estimate the Sensitivity and Specificity of Plain X-ray in Detecting Prosthetic Joint Infection
time frame: 15 mins
description: The adjudication committee evaluation of a subject's infection status will be used as the standard of truth to which X-ray is compared.
The trial failed primary outcome, and this secondary outcome was not analyzed.
measure: Determine the Sensitivity and Specificity of [124I]FIAU vs. Plain X-ray in Detecting Prosthetic Joint Infection
time frame: 30 hours
description: The adjudication committee evaluation of a subject's infection status will be used as the standard of truth to which [124I]FIAU and X-ray are compared.
The trial failed primary outcome, and this secondary outcome was not analyzed.
arm group label: [124I]FIAU
arm group type: Experimental
description: Single dose study of [124I]FIAU in patients presenting with pain in a prosthetic knee or hip joint who will undergo PET-CT scanning.
intervention type: Radiation
intervention name: [124I]FIAU
description: This is a single dose study of 5 mCi [124I]FIAU in subjects presenting with pain in a prosthetic knee or hip joint. Subject will receive two PET-CT scans after [124I]FIAU injection.
arm group label: [124I]FIAU
other name: Fialuridine
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Fialuridine
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 