<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/NCT02969564</url>
  </required_header>
  <id_info>
    <org_study_id>15-118</org_study_id>
    <nct_id>NCT02969564</nct_id>
  </id_info>
  <brief_title>18F-NaF-PET/MR vs 99mTc-MDP-SPECT/CT to Detect Bone Metastases in Prostate Cancer Patients.</brief_title>
  <official_title>18F-NaF-PET/MR vs 99mTc-MDP-SPECT/CT to Detect Bone Metastases in Prostate Cancer Patients.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Valentina Garibotto</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University Hospital, Geneva</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University Hospital, Geneva</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The number of metastases in a patient with primary or recurrent prostate cancer has major&#xD;
      prognostic implication.&#xD;
&#xD;
      The purpose is to compare, in a pilot study, the diagnostic performance of 18F-NaF-PET/MR&#xD;
      with respect to the results of the scintigraphy 99mTc-MDP-SPECT/CT (routine exam) for&#xD;
      determining the presence or absence of bone lesions in prostate cancer patient, with up to&#xD;
      five metastases (oligo-bone metastatic) based on scintigraphy 99mTc-MDP-SPECT/CT. The gold&#xD;
      standard will be a combination of clinical follow-up, additional imaging and biopsy, as&#xD;
      indicated by the multidisciplinary discussion at the tumor board. The findings from&#xD;
      whole-body 99mTc-MDP-SPECT/CT, 18F-NaF-PET/MR, and the combination of the 2 modalities will&#xD;
      be categorized by 2 teams of 2 readers as benign or probably benign, equivocal, or malignant&#xD;
      or probably malignant and compared with the results of follow-up for JAFROC and ROC analysis.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 2016</start_date>
  <completion_date type="Actual">September 14, 2020</completion_date>
  <primary_completion_date type="Actual">May 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Compare the diagnostic performance of 18F-NaF-PET/MR scanning to that of whole body 99mTc-MDP-SPECT/CT for detecting cancer that has spread to the bone (bone metastasis)</measure>
    <time_frame>through study completion, an average of 2 years</time_frame>
    <description>the primary measure will be differences in the area under the curves (AUC) of the receiver operating characteristic (ROC) curves that will be generated from the interpretations of each technology.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>To assess differences in sensitivity and specificity in detecting bone metastases between the two imaging modalities.</measure>
    <time_frame>through study completion, an average of 2 years</time_frame>
    <description>Sensitivity and specificity of PET and SPECT for the detection of secondary bone lesions (gold standard: clinical and imaging follow up)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To determine the number of equivocal and diagnostic tests resulting from the two imaging modalities.</measure>
    <time_frame>through study completion, an average of 2 years</time_frame>
    <description>rate of equivocal/non equivocal findings for the two modalities</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">12</enrollment>
  <condition>Bone Metastases</condition>
  <condition>Prostate Cancer</condition>
  <arm_group>
    <arm_group_label>prostate cancer patient, with up to five metastases</arm_group_label>
    <description>prostate cancer patient, with up to five metastases (oligo-bone metastatic) based on scintigraphy 99mTc-MDP-SPECT/CT.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>scintigraphy 99mTc-MDP-SPECT/CT.</intervention_name>
    <description>SPECT/CT will be performed for every patient in the frame of their clinical follow up</description>
    <arm_group_label>prostate cancer patient, with up to five metastases</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>18F-NaF-PET/MR</intervention_name>
    <description>a 18F-NaF-PET/MR will be performed, in the frame of this clinical study, to the patients to assess the difference of sensitivity of the 2 exams</description>
    <arm_group_label>prostate cancer patient, with up to five metastases</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Oligo- metastatic patient with prostate cancer and bone lesions (up to five metastases)&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Oligo- metastatic patient with prostate cancer and bone lesions (up to five&#xD;
             metastases) based on scintigraphy and whole-body SPECT/CT (staging or recurrence).&#xD;
&#xD;
          -  Patient must be able to provide informed consent.&#xD;
&#xD;
          -  Patient is ≥ 18 years old&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient with another active malignancy.&#xD;
&#xD;
          -  Patient is &lt; 18 years old&#xD;
&#xD;
          -  Patients with contraindications of MRI procedure (metal implants, cardiac pacemakers,&#xD;
             old type of prosthesis)&#xD;
&#xD;
          -  Patients with severe renal impairment (MDRD &lt; 30)&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Geneva University Hospital</name>
      <address>
        <city>Geneva</city>
        <zip>1205</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>April 21, 2016</study_first_submitted>
  <study_first_submitted_qc>November 16, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 21, 2016</study_first_posted>
  <last_update_submitted>November 2, 2020</last_update_submitted>
  <last_update_submitted_qc>November 2, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 4, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University Hospital, Geneva</investigator_affiliation>
    <investigator_full_name>Valentina Garibotto</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>prostate cancer</keyword>
  <keyword>bone metastases</keyword>
  <keyword>PET/MRI</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prostatic Neoplasms</mesh_term>
    <mesh_term>Neoplasm Metastasis</mesh_term>
    <mesh_term>Bone Neoplasms</mesh_term>
    <mesh_term>Bone Marrow Diseases</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Technetium Tc 99m Medronate</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT02969564
org study id: 15-118
nct id: NCT02969564
lead sponsor: 
collaborator: 
has dmc: No
The number of metastases in a patient with primary or recurrent prostate cancer has major
      prognostic implication.

      The purpose is to compare, in a pilot study, the diagnostic performance of 18F-NaF-PET/MR
      with respect to the results of the scintigraphy 99mTc-MDP-SPECT/CT (routine exam) for
      determining the presence or absence of bone lesions in prostate cancer patient, with up to
      five metastases (oligo-bone metastatic) based on scintigraphy 99mTc-MDP-SPECT/CT. The gold
      standard will be a combination of clinical follow-up, additional imaging and biopsy, as
      indicated by the multidisciplinary discussion at the tumor board. The findings from
      whole-body 99mTc-MDP-SPECT/CT, 18F-NaF-PET/MR, and the combination of the 2 modalities will
      be categorized by 2 teams of 2 readers as benign or probably benign, equivocal, or malignant
      or probably malignant and compared with the results of follow-up for JAFROC and ROC analysis.
observational model: Case-Only
time perspective: Prospective
measure: Compare the diagnostic performance of 18F-NaF-PET/MR scanning to that of whole body 99mTc-MDP-SPECT/CT for detecting cancer that has spread to the bone (bone metastasis)
time frame: through study completion, an average of 2 years
description: the primary measure will be differences in the area under the curves (AUC) of the receiver operating characteristic (ROC) curves that will be generated from the interpretations of each technology.
measure: To assess differences in sensitivity and specificity in detecting bone metastases between the two imaging modalities.
time frame: through study completion, an average of 2 years
description: Sensitivity and specificity of PET and SPECT for the detection of secondary bone lesions (gold standard: clinical and imaging follow up)
measure: To determine the number of equivocal and diagnostic tests resulting from the two imaging modalities.
time frame: through study completion, an average of 2 years
description: rate of equivocal/non equivocal findings for the two modalities
arm group label: prostate cancer patient, with up to five metastases
description: prostate cancer patient, with up to five metastases (oligo-bone metastatic) based on scintigraphy 99mTc-MDP-SPECT/CT.
intervention type: Other
intervention name: scintigraphy 99mTc-MDP-SPECT/CT.
description: SPECT/CT will be performed for every patient in the frame of their clinical follow up
arm group label: prostate cancer patient, with up to five metastases
intervention type: Other
intervention name: 18F-NaF-PET/MR
description: a 18F-NaF-PET/MR will be performed, in the frame of this clinical study, to the patients to assess the difference of sensitivity of the 2 exams
arm group label: prostate cancer patient, with up to five metastases
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Male
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Switzerland
responsible party type: Sponsor-Investigator
investigator affiliation: University Hospital, Geneva
investigator full name: Valentina Garibotto
investigator title: Professor
mesh term: Prostatic Neoplasms
mesh term: Neoplasm Metastasis
mesh term: Bone Neoplasms
mesh term: Bone Marrow Diseases
mesh term: Technetium Tc 99m Medronate