<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/NCT02205788</url>
  </required_header>
  <id_info>
    <org_study_id>IUCRO-0479</org_study_id>
    <secondary_id>1405049285</secondary_id>
    <nct_id>NCT02205788</nct_id>
  </id_info>
  <brief_title>Feasibility of Biodynamic Imaging for Predicting Therapeutic Effect in Metastatic Adenocarcinoma of the Pancreas</brief_title>
  <official_title>Feasibility of Biodynamic Imaging for Predicting Effect of Gemcitabine and Nab-paclitaxel on Metastatic Adenocarcinoma of the Pancreas</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Patrick Joseph Loehrer Sr.</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Indiana University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine if you can use an assay on tumor samples to see&#xD;
      different patterns in response to the same chemotherapy treatment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      To examine the feasibility of using biodynamic imaging (BDI) as a chemosensitivity assay on&#xD;
      fresh tumor samples obtained by core needle biopsy from patients planned to receive routine&#xD;
      care gemcitabine and nab-paclitaxel for treatment of metastatic adenocarcinoma of the&#xD;
      pancreas.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">September 14, 2016</completion_date>
  <primary_completion_date type="Actual">September 14, 2016</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>BDI as a chemosensitivity assay on fresh tumor samples</measure>
    <time_frame>up to 336 days</time_frame>
    <description>To examine the feasibility of using BDI as a chemosensitivity assay on fresh tumor samples obtained by core needle biopsy from patients planned to receive routine care gemcitabine and nab-paclitaxel for treatment of metastatic adenocarcinoma of the pancreas.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>BDI patterns and results with Response Evaluation Criteria</measure>
    <time_frame>up to 336 days</time_frame>
    <description>To compare BDI patterns consistent with chemotherapy response ex-vivo to response to chemotherapy as measured by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria.</description>
  </secondary_outcome>
  <enrollment type="Actual">0</enrollment>
  <condition>Metastatic Pancreatic Cancer</condition>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      core needle biopsy of tumor&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        primary care clinic and Cancer Clinic patients&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Ability to understand and willingness to sign an informed consent and authorization&#xD;
             for release of health information for research&#xD;
&#xD;
          2. ≥ 18 years old at time of consent&#xD;
&#xD;
          3. Patients with a diagnosis of metastatic pancreatic cancer (mPC) who have not received&#xD;
             prior combination chemotherapy. Exception: prior adjuvant chemoradiation with&#xD;
             fluorouracil or gemcitabine is allowed.&#xD;
&#xD;
          4. Patients considered for routine care treatment with gemcitabine and nab-paclitaxel&#xD;
             (allowed to receive other experimental therapy with gem/nab backbone if participating&#xD;
             in another clinical trial)&#xD;
&#xD;
          5. Measurable disease by RECIST v1.1 criteria&#xD;
&#xD;
          6. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1&#xD;
&#xD;
          7. Willingness to undergo transcutaneous core needle biopsy of metastatic tumor for&#xD;
             research purposes&#xD;
&#xD;
          8. Women are eligible to participate if they are of non-childbearing potential or have&#xD;
             documentation of a negative pregnancy test (serum or urine β-hCG) within 1 week of the&#xD;
             start of protocol treatment.&#xD;
&#xD;
          9. Women and men of childbearing potential must agree to use adequate, highly effective&#xD;
             contraceptive measures during protocol treatment&#xD;
&#xD;
         10. Laboratory values: Platelets ≥ 100 K/mm3 international normalized ratio (INR) &lt; 1.2,&#xD;
             Partial thromboplastin time (PTT) in normal range, Cr &lt; 2.0, Total bilirubin &lt; 2 times&#xD;
             upper limit normal (ULN), transaminases &lt; 5 times ULN&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. History of abnormal bleeding with minor procedures or documented platelet aggregation&#xD;
             disorder such as VonWillebrand disease&#xD;
&#xD;
          2. Women who are pregnant or breastfeeding&#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>Bert O'Neil, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Indiana University</affiliation>
  </overall_official>
  <removed_countries>
    <country>United States</country>
  </removed_countries>
  <verification_date>July 2019</verification_date>
  <study_first_submitted>July 10, 2014</study_first_submitted>
  <study_first_submitted_qc>July 30, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 31, 2014</study_first_posted>
  <last_update_submitted>July 8, 2019</last_update_submitted>
  <last_update_submitted_qc>July 8, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 10, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Indiana University</investigator_affiliation>
    <investigator_full_name>Patrick Joseph Loehrer Sr.</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Adenocarcinoma</mesh_term>
  </condition_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/NCT02205788
org study id: IUCRO-0479
secondary id: 1405049285
nct id: NCT02205788
lead sponsor: 
has dmc: Yes
The purpose of this study is to determine if you can use an assay on tumor samples to see
      different patterns in response to the same chemotherapy treatment.
To examine the feasibility of using biodynamic imaging (BDI) as a chemosensitivity assay on
      fresh tumor samples obtained by core needle biopsy from patients planned to receive routine
      care gemcitabine and nab-paclitaxel for treatment of metastatic adenocarcinoma of the
      pancreas.
observational model: Case-Control
time perspective: Prospective
measure: BDI as a chemosensitivity assay on fresh tumor samples
time frame: up to 336 days
description: To examine the feasibility of using BDI as a chemosensitivity assay on fresh tumor samples obtained by core needle biopsy from patients planned to receive routine care gemcitabine and nab-paclitaxel for treatment of metastatic adenocarcinoma of the pancreas.
measure: BDI patterns and results with Response Evaluation Criteria
time frame: up to 336 days
description: To compare BDI patterns consistent with chemotherapy response ex-vivo to response to chemotherapy as measured by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria.
core needle biopsy of tumor
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Bert O'Neil, MD
role: Principal Investigator
affiliation: Indiana University
country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: Indiana University
investigator full name: Patrick Joseph Loehrer Sr.
investigator title: Professor
mesh term: Adenocarcinoma