<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/NCT01722058</url>
  </required_header>
  <id_info>
    <org_study_id>HUM00068009</org_study_id>
    <nct_id>NCT01722058</nct_id>
  </id_info>
  <brief_title>A Phase I In-Vivo Peptide Applied in the Right Colon</brief_title>
  <official_title>A Phase I In-Vivo Colon Protocol for Detection of Neoplasia in the Digestive Tract (U54)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Michigan</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Michigan</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      You are invited to participate in a research study to develop new ways to look for abnormal&#xD;
      areas/tissues of the colon. The current endoscopes used to look at the colon are very good,&#xD;
      but if the area doesn't look different to the naked eye, then the endoscope can't improve on&#xD;
      that. We are looking at using special fluorescent stains in addition to special endoscopes&#xD;
      designed to see abnormal areas that are not obvious to the naked eye. Currently specialized&#xD;
      microscopes and fluorescent stains are used in clinical laboratories but it takes several&#xD;
      days of processing to get results. It may be very helpful to look for areas to sample for&#xD;
      abnormal tissue during the endoscopy procedure.&#xD;
&#xD;
      You are being asked to let us spray a &quot;fluorescent peptides&quot; into your right colon. Peptides&#xD;
      are small chains of amino acids (the building blocks that make up proteins) linked together.&#xD;
      Our peptide is a chain of 7 amino acids attached to a fluorescent dye called FITC (like the&#xD;
      one used by your eye doctor).&#xD;
&#xD;
      We have prepared this special &quot;fluorescent peptide&quot; to target and bind to any abnormal areas&#xD;
      if present, and &quot;glow&quot; when a special light is used. In this study, we will apply the special&#xD;
      fluorescent peptide by a spray catheter to your right colon to asses for safety. The&#xD;
      colonoscope used in this study is the usual colonoscope used and is not able to see the&#xD;
      fluorescence.&#xD;
&#xD;
      This is a phase 1 study. This means that this is the first time we have used this kind of&#xD;
      &quot;fluorescent peptide&quot; in people. The Food and Drug Administration (FDA) has not approved this&#xD;
      agent, but is allowing us to test it in this study. The goal of this study is to see if there&#xD;
      are any side effects from using the peptide. We have used a similar peptide that we've&#xD;
      developed for the esophagus in over 40 patients without any side effects.&#xD;
&#xD;
      This is the first test of this agent, so it won't be used to change how colonoscopy is done.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The goal of this research is to develop the use of fluorescence-labeled peptides (Colon KCC)&#xD;
      that affinity bind to pre-cancerous mucosa in the digestive tract for use as an imaging agent&#xD;
      to aid in the early detection of colon cancer. Currently colon cancer prevention is achieved&#xD;
      by endoscopic evaluation and removal of pre-malignant lesions (adenomatous polyps) by&#xD;
      endoscopic resection and biopsy. Standard endoscopy uses white light illumination and is only&#xD;
      able to detect pre-cancerous tissue that has abnormal architectural features, such as a polyp&#xD;
      or mass. However, pre-cancerous lesions can also be flat in appearance and visually&#xD;
      indistinct from normal tissue; such as in the case of chronic ulcerative colitis and / or&#xD;
      some right-sided polyps.&#xD;
&#xD;
      Furthermore, flat and depressed lesions, which are more difficult to detect in white light&#xD;
      colonoscopy, may represent over 25% of all pre-malignant lesions and may confer a higher risk&#xD;
      for malignancy. Integration of molecular probes that home in to diseased tissues with high&#xD;
      resolution imaging instruments could greatly improve the diagnostic accuracy for missed&#xD;
      lesions of both polypoid and non-polypoid morphology, including the often fatal 'right-sided&#xD;
      ' adenomas.&#xD;
&#xD;
      Endoscopic imaging with the use of fluorescent-labeled probes is a promising method for&#xD;
      achieving greater specificity, spatial localization and higher image contrast in the&#xD;
      detection of neoplastic lesions. This study is a 'first-in-humans' test of the safety of the&#xD;
      topically applied peptide.&#xD;
&#xD;
      A Phase I study of the safety of a topically-administered fluorescent heptapeptide for&#xD;
      detecting neoplastic areas of the colon is proposed. The study will test the safety of&#xD;
      administering this agent to human subjects undergoing clinically-indicated colonoscopy.&#xD;
      Safety is defined as the occurrence of adverse events after the administration of topical&#xD;
      fluorescence-labeled peptides to the surface of intra-colonic mucosa.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>February 2013</start_date>
  <completion_date type="Actual">August 2013</completion_date>
  <primary_completion_date type="Actual">June 2013</primary_completion_date>
  <phase>Phase 1</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>Application of peptide to 25 subjects undergoing colonoscopy</measure>
    <time_frame>6 months</time_frame>
    <description>To evaluate the safety of topically administered fluorescence-labeled peptides to the surface of intra-colonic mucosa.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">25</enrollment>
  <condition>Colon Lesions</condition>
  <arm_group>
    <arm_group_label>peptide application</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Peptide application</intervention_name>
    <arm_group_label>peptide application</arm_group_label>
    <other_name>Colon KCC Heptapeptide (5-FITC-labeled peptide)</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        The inclusion criteria for this proposed clinical study are:&#xD;
&#xD;
          -  Subjects who are scheduled for outpatient colonoscopy.&#xD;
&#xD;
          -  All subjects who are medically cleared for the procedure (e.g. washout for&#xD;
             anticoagulants, comorbidities) who meet the inclusion/exclusion will be included.&#xD;
             Standard practice guidelines for safely proceeding with the procedure will be&#xD;
             sufficient for our study&#xD;
&#xD;
          -  Adults aged 18 years to 100&#xD;
&#xD;
          -  Willing and able to sign informed consent&#xD;
&#xD;
          -  Willing and able to get the repeat clinical labs&#xD;
&#xD;
          -  The effects of the Colon KCC Heptapeptide (labeled with 5-FITC) on the developing&#xD;
             human fetus are unknown. For this reason, women of child-bearing potential must have a&#xD;
             negative pregnancy test on the day of the procedure to receiving the Colon KCC&#xD;
             Heptapeptide (5-FITC-labeled peptide) agent or be post-menopausal. Post-menopausal&#xD;
             women are defined as post-hysterectomy, or over 40 and at least 18 months without&#xD;
             menses and not on birth-control.&#xD;
&#xD;
        The exclusion criteria for this proposed clinical study are:&#xD;
&#xD;
          -  Subjects with known allergy or negative reaction to fluorescein or derivatives.&#xD;
&#xD;
          -  Subjects on active chemotherapy or radiation treatment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Danielle Kim Turgeon, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Michigan</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Michigan</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2013</verification_date>
  <study_first_submitted>October 30, 2012</study_first_submitted>
  <study_first_submitted_qc>November 2, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 6, 2012</study_first_posted>
  <last_update_submitted>November 14, 2013</last_update_submitted>
  <last_update_submitted_qc>November 14, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 15, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Michigan</investigator_affiliation>
    <investigator_full_name>Missy Tuck</investigator_full_name>
    <investigator_title>Project Manager</investigator_title>
  </responsible_party>
  <keyword>peptide</keyword>
  <keyword>colon</keyword>
  <keyword>flat lesions</keyword>
  <!-- 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/NCT01722058
org study id: HUM00068009
nct id: NCT01722058
lead sponsor: 
has dmc: Yes
You are invited to participate in a research study to develop new ways to look for abnormal
      areas/tissues of the colon. The current endoscopes used to look at the colon are very good,
      but if the area doesn't look different to the naked eye, then the endoscope can't improve on
      that. We are looking at using special fluorescent stains in addition to special endoscopes
      designed to see abnormal areas that are not obvious to the naked eye. Currently specialized
      microscopes and fluorescent stains are used in clinical laboratories but it takes several
      days of processing to get results. It may be very helpful to look for areas to sample for
      abnormal tissue during the endoscopy procedure.

      You are being asked to let us spray a "fluorescent peptides" into your right colon. Peptides
      are small chains of amino acids (the building blocks that make up proteins) linked together.
      Our peptide is a chain of 7 amino acids attached to a fluorescent dye called FITC (like the
      one used by your eye doctor).

      We have prepared this special "fluorescent peptide" to target and bind to any abnormal areas
      if present, and "glow" when a special light is used. In this study, we will apply the special
      fluorescent peptide by a spray catheter to your right colon to asses for safety. The
      colonoscope used in this study is the usual colonoscope used and is not able to see the
      fluorescence.

      This is a phase 1 study. This means that this is the first time we have used this kind of
      "fluorescent peptide" in people. The Food and Drug Administration (FDA) has not approved this
      agent, but is allowing us to test it in this study. The goal of this study is to see if there
      are any side effects from using the peptide. We have used a similar peptide that we've
      developed for the esophagus in over 40 patients without any side effects.

      This is the first test of this agent, so it won't be used to change how colonoscopy is done.
The goal of this research is to develop the use of fluorescence-labeled peptides (Colon KCC)
      that affinity bind to pre-cancerous mucosa in the digestive tract for use as an imaging agent
      to aid in the early detection of colon cancer. Currently colon cancer prevention is achieved
      by endoscopic evaluation and removal of pre-malignant lesions (adenomatous polyps) by
      endoscopic resection and biopsy. Standard endoscopy uses white light illumination and is only
      able to detect pre-cancerous tissue that has abnormal architectural features, such as a polyp
      or mass. However, pre-cancerous lesions can also be flat in appearance and visually
      indistinct from normal tissue; such as in the case of chronic ulcerative colitis and / or
      some right-sided polyps.

      Furthermore, flat and depressed lesions, which are more difficult to detect in white light
      colonoscopy, may represent over 25% of all pre-malignant lesions and may confer a higher risk
      for malignancy. Integration of molecular probes that home in to diseased tissues with high
      resolution imaging instruments could greatly improve the diagnostic accuracy for missed
      lesions of both polypoid and non-polypoid morphology, including the often fatal 'right-sided
      ' adenomas.

      Endoscopic imaging with the use of fluorescent-labeled probes is a promising method for
      achieving greater specificity, spatial localization and higher image contrast in the
      detection of neoplastic lesions. This study is a 'first-in-humans' test of the safety of the
      topically applied peptide.

      A Phase I study of the safety of a topically-administered fluorescent heptapeptide for
      detecting neoplastic areas of the colon is proposed. The study will test the safety of
      administering this agent to human subjects undergoing clinically-indicated colonoscopy.
      Safety is defined as the occurrence of adverse events after the administration of topical
      fluorescence-labeled peptides to the surface of intra-colonic mucosa.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Application of peptide to 25 subjects undergoing colonoscopy
time frame: 6 months
description: To evaluate the safety of topically administered fluorescence-labeled peptides to the surface of intra-colonic mucosa.
arm group label: peptide application
arm group type: Experimental
intervention type: Drug
intervention name: Peptide application
arm group label: peptide application
other name: Colon KCC Heptapeptide (5-FITC-labeled peptide)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Danielle Kim Turgeon, M.D.
role: Principal Investigator
affiliation: University of Michigan
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Michigan
investigator full name: Missy Tuck
investigator title: Project Manager