<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/NCT01698710</url>
  </required_header>
  <id_info>
    <org_study_id>12-178</org_study_id>
    <nct_id>NCT01698710</nct_id>
  </id_info>
  <brief_title>Endoscopic Abraxane Injection Into Pancreatic Cysts</brief_title>
  <official_title>EUS Guided Injection of Albumin Bound Paclitaxel Into Pancreatic Cysts</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Massachusetts General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Massachusetts General Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This research study is a pilot study. In this pilot study we are testing the safety of a&#xD;
      procedure. &quot;Investigational&quot; means that the Albumin bound paclitaxel (Abraxane) is still&#xD;
      being studied and that research doctors are trying to find out more about it. It also means&#xD;
      that the FDA has not approved Abraxane injection for your type of medical condition.&#xD;
      Treatment of pancreatic cysts often requires follow-up imaging studies and surgical resection&#xD;
      of the cysts. As part of standard medical care, you will be undergoing a diagnostic&#xD;
      endoscopic ultrasound guided fine needle aspiration (EUS-FNA) in order to evaluate type of&#xD;
      the cyst. During the EUS and just after the cyst fluid aspiration, you will undergo the&#xD;
      injection of the drug into the cyst cavity if your cyst is thought to be cancerous or&#xD;
      precancerous. Cyst fluid will be analyzed for further diagnosis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      You will be asked to undergo some screening tests or procedures to find out if you can be in&#xD;
      the research study. Many of these tests and procedures are likely to be part of regular&#xD;
      cancer care and may be done even if it turns out that you do not take part in the research&#xD;
      study. If you have had some of these tests or procedures recently, they may or may not have&#xD;
      to be repeated. Screening tests include the following: medical history, performance status,&#xD;
      assessment of pancreatic cyst by CT, MRI or EUS, blood tests and a pregnancy test.&#xD;
&#xD;
      If these tests show that you are eligible to participate in the research study, you will&#xD;
      begin the study treatment. If you do not meet the eligibility criteria you will not be able&#xD;
      to participate in this research study.&#xD;
&#xD;
      As part of your medical care you will be undergoing an endoscopic procedure EUS-FNA&#xD;
      (Endoscopic Ultrasound Fine Needle Aspiration) in order to evaluate and evacuate the cyst&#xD;
      fluid. During the EUS-FNA and just after the cyst fluid aspiration, albumin bound paclitaxel&#xD;
      will be injected into the cyst cavity.&#xD;
&#xD;
      The study procedure (injection of drug into cyst cavity) takes place over 5 minutes during&#xD;
      the EUS-FNA. 2 days after the procedure you will receive a phone call from the research&#xD;
      coordinator to check on how you are feeling. 3 months after study procedure participants will&#xD;
      undergo a follow up CT to see what happened to the cyst. You will continue to have routine&#xD;
      follow up for your medical problems.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    expiration of IRB approval&#xD;
  </why_stopped>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">September 2014</completion_date>
  <primary_completion_date type="Actual">September 2014</primary_completion_date>
  <phase>N/A</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Frequency of Pancreatitis</measure>
    <time_frame>3-10 months (median 6 months) after injection therapy</time_frame>
    <description>Safety of injection of albumin-bound paclitaxel will be measured by the frequency of pancreatitis.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Feasibility of Endoscopic Ultrasonography (EUS) Guided Injection of Albumin-bound Paclitaxel Into Pancreatic Cysts</measure>
    <time_frame>immediately after procedure</time_frame>
    <description>The feasibility of the procedure will be measured by the ease of injection of albumin-bound paclitaxel into the cyst cavity across the gastro-duodenal wall. On a subjective scale, the endoscopist will note the ease of the procedure on a scale of 0-5, with 5 being very easy and 0 is not possible. Any score less than 2 will be considered unacceptable and failure of the study.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Size of Cystic Lesion</measure>
    <time_frame>3-10 months (median 6 months) after injection therapy</time_frame>
    <description>Determine the size of the cystic lesion using CT scanning. Number of participants with reduction in size, persistent size, or increase in size of cyst are reported.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">5</enrollment>
  <condition>Pancreatic Cysts</condition>
  <arm_group>
    <arm_group_label>Albumin bound paclitaxel</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Albumin bound paclitaxel will be administered into the mucinous cyst of pancreas in endoscopy procedure.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Albumin bound paclitaxel</intervention_name>
    <description>Albumin bound paclitaxel will be administered into the mucinous cyst of pancreas in endoscopy procedure.</description>
    <arm_group_label>Albumin bound paclitaxel</arm_group_label>
    <other_name>Abraxane</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Mucinous cysts (premalignant or malignant cysts of the pancreas)&#xD;
&#xD;
          -  Normal organ and marrow function&#xD;
&#xD;
          -  Baseline CT within 6 months of enrollment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant or breastfeeding&#xD;
&#xD;
          -  Acute active pancreatitis&#xD;
&#xD;
          -  Complicated pancreatic cysts&#xD;
&#xD;
          -  Subjects who do not speak English&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>William Brugge, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Massachusetts General Hospital</affiliation>
  </overall_official>
  <removed_countries>
    <country>United States</country>
  </removed_countries>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>October 1, 2012</study_first_submitted>
  <study_first_submitted_qc>October 1, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 3, 2012</study_first_posted>
  <results_first_submitted>May 26, 2017</results_first_submitted>
  <results_first_submitted_qc>May 26, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">June 21, 2017</results_first_posted>
  <last_update_submitted>May 26, 2017</last_update_submitted>
  <last_update_submitted_qc>May 26, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">June 21, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Massachusetts General Hospital</investigator_affiliation>
    <investigator_full_name>William R. Brugge, MD</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Premalignant</keyword>
  <keyword>Malignant</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cysts</mesh_term>
    <mesh_term>Pancreatic Cyst</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Paclitaxel</mesh_term>
    <mesh_term>Albumin-Bound Paclitaxel</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Albumin Bound Paclitaxel</title>
          <description>Albumin bound paclitaxel will be administered into the mucinous cyst of pancreas in endoscopy procedure.&#xD;
Albumin bound paclitaxel: Albumin bound paclitaxel will be administered into the mucinous cyst of pancreas in endoscopy procedure.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Albumin Bound Paclitaxel</title>
          <description>Albumin bound paclitaxel will be administered into the mucinous cyst of pancreas in endoscopy procedure.&#xD;
Albumin bound paclitaxel: Albumin bound paclitaxel will be administered into the mucinous cyst of pancreas in endoscopy procedure.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="5"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                  </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="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Cyst diameter</title>
          <description>Patients with clinically diagnosed mucinous cysts (premalignant or malignant cysts of the pancreas) including mucinous cystic neoplasms and intraductal papillary mucinous neoplasms were eligible.</description>
          <units>mm</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="28.4" lower_limit="23" upper_limit="35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Location of cyst</title>
          <description>Patients with clinically diagnosed mucinous cysts (premalignant or malignant cysts of the pancreas) including mucinous cystic neoplasms and intraductal papillary mucinous neoplasms were eligible.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Head</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Body</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Frequency of Pancreatitis</title>
        <description>Safety of injection of albumin-bound paclitaxel will be measured by the frequency of pancreatitis.</description>
        <time_frame>3-10 months (median 6 months) after injection therapy</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Albumin Bound Paclitaxel</title>
            <description>Albumin bound paclitaxel will be administered into the mucinous cyst of pancreas in endoscopy procedure.&#xD;
Albumin bound paclitaxel: Albumin bound paclitaxel will be administered into the mucinous cyst of pancreas in endoscopy procedure.</description>
          </group>
        </group_list>
        <measure>
          <title>Frequency of Pancreatitis</title>
          <description>Safety of injection of albumin-bound paclitaxel will be measured by the frequency of pancreatitis.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Feasibility of Endoscopic Ultrasonography (EUS) Guided Injection of Albumin-bound Paclitaxel Into Pancreatic Cysts</title>
        <description>The feasibility of the procedure will be measured by the ease of injection of albumin-bound paclitaxel into the cyst cavity across the gastro-duodenal wall. On a subjective scale, the endoscopist will note the ease of the procedure on a scale of 0-5, with 5 being very easy and 0 is not possible. Any score less than 2 will be considered unacceptable and failure of the study.</description>
        <time_frame>immediately after procedure</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Albumin Bound Paclitaxel</title>
            <description>Albumin bound paclitaxel will be administered into the mucinous cyst of pancreas in endoscopy procedure.&#xD;
Albumin bound paclitaxel: Albumin bound paclitaxel will be administered into the mucinous cyst of pancreas in endoscopy procedure.</description>
          </group>
        </group_list>
        <measure>
          <title>Feasibility of Endoscopic Ultrasonography (EUS) Guided Injection of Albumin-bound Paclitaxel Into Pancreatic Cysts</title>
          <description>The feasibility of the procedure will be measured by the ease of injection of albumin-bound paclitaxel into the cyst cavity across the gastro-duodenal wall. On a subjective scale, the endoscopist will note the ease of the procedure on a scale of 0-5, with 5 being very easy and 0 is not possible. Any score less than 2 will be considered unacceptable and failure of the study.</description>
          <units>units on a scale</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4" lower_limit="3" upper_limit="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Size of Cystic Lesion</title>
        <description>Determine the size of the cystic lesion using CT scanning. Number of participants with reduction in size, persistent size, or increase in size of cyst are reported.</description>
        <time_frame>3-10 months (median 6 months) after injection therapy</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Albumin Bound Paclitaxel</title>
            <description>Albumin bound paclitaxel will be administered into the mucinous cyst of pancreas in endoscopy procedure.&#xD;
Albumin bound paclitaxel: Albumin bound paclitaxel will be administered into the mucinous cyst of pancreas in endoscopy procedure.</description>
          </group>
        </group_list>
        <measure>
          <title>Size of Cystic Lesion</title>
          <description>Determine the size of the cystic lesion using CT scanning. Number of participants with reduction in size, persistent size, or increase in size of cyst are reported.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Reduction</title>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Persistent</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Increase</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Albumin Bound Paclitaxel</title>
          <description>Albumin bound paclitaxel will be administered into the mucinous cyst of pancreas in endoscopy procedure.&#xD;
Albumin bound paclitaxel: Albumin bound paclitaxel will be administered into the mucinous cyst of pancreas in endoscopy procedure.</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="0" subjects_at_risk="5"/>
              </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="0" subjects_at_risk="5"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. William Brugge</name_or_title>
      <organization>Massachusetts General Hospital</organization>
      <phone>6173083532</phone>
      <email>Brugge.William@mgh.harvard.edu</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/NCT01698710
org study id: 12-178
nct id: NCT01698710
lead sponsor: 
has dmc: Yes
This research study is a pilot study. In this pilot study we are testing the safety of a
      procedure. "Investigational" means that the Albumin bound paclitaxel (Abraxane) is still
      being studied and that research doctors are trying to find out more about it. It also means
      that the FDA has not approved Abraxane injection for your type of medical condition.
      Treatment of pancreatic cysts often requires follow-up imaging studies and surgical resection
      of the cysts. As part of standard medical care, you will be undergoing a diagnostic
      endoscopic ultrasound guided fine needle aspiration (EUS-FNA) in order to evaluate type of
      the cyst. During the EUS and just after the cyst fluid aspiration, you will undergo the
      injection of the drug into the cyst cavity if your cyst is thought to be cancerous or
      precancerous. Cyst fluid will be analyzed for further diagnosis.
You will be asked to undergo some screening tests or procedures to find out if you can be in
      the research study. Many of these tests and procedures are likely to be part of regular
      cancer care and may be done even if it turns out that you do not take part in the research
      study. If you have had some of these tests or procedures recently, they may or may not have
      to be repeated. Screening tests include the following: medical history, performance status,
      assessment of pancreatic cyst by CT, MRI or EUS, blood tests and a pregnancy test.

      If these tests show that you are eligible to participate in the research study, you will
      begin the study treatment. If you do not meet the eligibility criteria you will not be able
      to participate in this research study.

      As part of your medical care you will be undergoing an endoscopic procedure EUS-FNA
      (Endoscopic Ultrasound Fine Needle Aspiration) in order to evaluate and evacuate the cyst
      fluid. During the EUS-FNA and just after the cyst fluid aspiration, albumin bound paclitaxel
      will be injected into the cyst cavity.

      The study procedure (injection of drug into cyst cavity) takes place over 5 minutes during
      the EUS-FNA. 2 days after the procedure you will receive a phone call from the research
      coordinator to check on how you are feeling. 3 months after study procedure participants will
      undergo a follow up CT to see what happened to the cyst. You will continue to have routine
      follow up for your medical problems.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Frequency of Pancreatitis
time frame: 3-10 months (median 6 months) after injection therapy
description: Safety of injection of albumin-bound paclitaxel will be measured by the frequency of pancreatitis.
measure: Feasibility of Endoscopic Ultrasonography (EUS) Guided Injection of Albumin-bound Paclitaxel Into Pancreatic Cysts
time frame: immediately after procedure
description: The feasibility of the procedure will be measured by the ease of injection of albumin-bound paclitaxel into the cyst cavity across the gastro-duodenal wall. On a subjective scale, the endoscopist will note the ease of the procedure on a scale of 0-5, with 5 being very easy and 0 is not possible. Any score less than 2 will be considered unacceptable and failure of the study.
measure: Size of Cystic Lesion
time frame: 3-10 months (median 6 months) after injection therapy
description: Determine the size of the cystic lesion using CT scanning. Number of participants with reduction in size, persistent size, or increase in size of cyst are reported.
arm group label: Albumin bound paclitaxel
arm group type: Experimental
description: Albumin bound paclitaxel will be administered into the mucinous cyst of pancreas in endoscopy procedure.
intervention type: Drug
intervention name: Albumin bound paclitaxel
description: Albumin bound paclitaxel will be administered into the mucinous cyst of pancreas in endoscopy procedure.
arm group label: Albumin bound paclitaxel
other name: Abraxane
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: William Brugge, MD
role: Principal Investigator
affiliation: Massachusetts General Hospital
country: United States
responsible party type: Principal Investigator
investigator affiliation: Massachusetts General Hospital
investigator full name: William R. Brugge, MD
investigator title: Principal Investigator
mesh term: Cysts
mesh term: Pancreatic Cyst
mesh term: Paclitaxel
mesh term: Albumin-Bound Paclitaxel
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 