<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/NCT03272659</url>
  </required_header>
  <id_info>
    <org_study_id>17-140</org_study_id>
    <nct_id>NCT03272659</nct_id>
  </id_info>
  <brief_title>The Correlation of Surgical Colorectal Cancer Specimen Pathology With the Fluorescence of Photodynamic Diagnostics</brief_title>
  <acronym>PDD</acronym>
  <official_title>The Correlation of Surgical Colorectal Cancer Specimen Pathology With the Fluorescence of Photodynamic Diagnostics (PDD): a Clinical Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Dr. Te Vuong</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>KARL STORZ Endoscopy-America, Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Sir Mortimer B. Davis - Jewish General Hospital</source>
  <oversight_info>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This will be a pilot study involving 5 patients diagnosed with colorectal carcinoma and&#xD;
      treated with pre-operative chemotherapy and external beam radiation therapy at the Jewish&#xD;
      General Hospital, whom will very soon undergo surgery. Participants will be sensitized by the&#xD;
      instillation of a 250 mL enema containing 1.6 mmol of HAL. The enema will be administered&#xD;
      with a plastic tube with an inflatable blocking balloon to prevent leakage of the enema.&#xD;
      Fluorescence sigmoidoscopy will be performed with white light then blue excitation light&#xD;
      after retention of the enema for 60 minutes, followed by a rest time of up to 30 minutes&#xD;
      before rectoscopy. Red fluorescence should be induced by illumination with blue light.&#xD;
      Pictures with and without fluorescence will be taken. The patients will undergo a colectomy&#xD;
      (partial or complete) within the next 2-3 days and the surgical specimens will be collected&#xD;
      for further fluorescence microscopy studies and pathological correlation of fluoresce with&#xD;
      malignant pathology/histology as the gold standard. The total concentration of porphyrins in&#xD;
      the patients' urine and serum will be recorded before sensitization, immediately after&#xD;
      sensitization (instillation of the enema), and approximately 24 hours after sensitization.&#xD;
      The patients' pre-and-post operative liver function tests will be measured. Adverse events&#xD;
      will be reported by direct questioning of all patients with regards to photosensitivity and&#xD;
      gastrointestinal symptoms (nausea, vomiting), and by measuring blood pressure and heart rate.&#xD;
      Our objectives and endpoints are: 1) to determine if fluorescence with photodynamic&#xD;
      diagnostics is selective for colorectal cancer, 2) to determine if photodynamic diagnostics&#xD;
      has the potential to improve the detection of malignant cell after neoadjuvant chemotherapy&#xD;
      and radiation, and 3) to determine if photodynamic diagnostics can provide an accurate&#xD;
      depiction of the extent of disease burden not visible with normal white light sigmoidoscopy&#xD;
      to the naked human eye.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Long process and due to strict deadline, project was stopped.&#xD;
  </why_stopped>
  <start_date type="Anticipated">April 1, 2018</start_date>
  <completion_date type="Anticipated">April 1, 2019</completion_date>
  <primary_completion_date type="Anticipated">December 1, 2018</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>fluorescence with photodynamic diagnostics (PDD) in colorectal cancer</measure>
    <time_frame>9 months</time_frame>
    <description>To observe red fluorescence wirh PDD when lesions are illuminate with blue fluorescence during fluorescence sigmoidoscopy.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Detect malignant lesions</measure>
    <time_frame>9 months</time_frame>
    <description>Using the images of fluorescence sigmoidoscopy, detect malignant lesions after neoadjuvant chemotherapy and radiation.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Accurate depiction of the extent of disease burden by correlating pre-and post surgical results after neoadjuvant chemotherapy and radiation.</measure>
    <time_frame>9 months</time_frame>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Colorectal Cancer</condition>
  <condition>Photodynamic Diagnosis</condition>
  <arm_group>
    <arm_group_label>Blue Light Cystoscopy with Cysview®</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The enema will be administered to participant. Fluorescence sigmoidoscopy will be performed with white light then blue excitation light after retention of the enema for 60 minutes, followed by a rest time of up to 30 minutes before rectoscopy.&#xD;
Post-operative surgical specimens will be collected for further fluorescence microscopy studies and pathological correlation of fluoresce with malignant pathology/histology as the gold standard.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cysview</intervention_name>
    <description>250 mL enema containing 1.6 mmol of hexaminolevulinate</description>
    <arm_group_label>Blue Light Cystoscopy with Cysview®</arm_group_label>
    <other_name>hexaminolevulinate</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients older than 18 years of age with diagnosed colorectal cancer.&#xD;
&#xD;
          -  Colorectal cancer patients treated with Chemotherapy and external beam radiation&#xD;
             therapy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  1) Liver cirrhosis&#xD;
&#xD;
          -  2) Acute or chronic hepatitis&#xD;
&#xD;
          -  3) Elevated liver function tests of unknown etiology with elevation of transaminases&#xD;
             of more than 3 times normal levels&#xD;
&#xD;
          -  4) Known porphyria&#xD;
&#xD;
          -  5) Pregnancy&#xD;
&#xD;
          -  6) Expected lack of compliance&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <reference>
    <citation>Endlicher E, Gelbmann CM, Knuchel R, Furst A, Szeimies RM, Golder SK, Scholmerich J, Lottner C, Messmann H. Hexaminolevulinate-induced fluorescence endoscopy in patients with rectal adenoma and cancer: a pilot study. Gastrointest Endosc. 2004 Sep;60(3):449-54. doi: 10.1016/s0016-5107(04)01723-7.</citation>
    <PMID>15332045</PMID>
  </reference>
  <reference>
    <citation>Mayinger B, Neumann F, Kastner C, Degitz K, Hahn EG, Schwab D. Early detection of premalignant conditions in the colon by fluorescence endoscopy using local sensitization with hexaminolevulinate. Endoscopy. 2008 Feb;40(2):106-9. doi: 10.1055/s-2007-967019. Epub 2008 Jan 16.</citation>
    <PMID>18197583</PMID>
  </reference>
  <reference>
    <citation>Mayinger B, Neumann F, Kastner C, Haider T, Schwab D. Hexaminolevulinate-induced fluorescence colonoscopy versus white light endoscopy for diagnosis of neoplastic lesions in the colon. Endoscopy. 2010 Jan;42(1):28-33. doi: 10.1055/s-0029-1243804. Epub 2010 Jan 11.</citation>
    <PMID>20066590</PMID>
  </reference>
  <reference>
    <citation>Pietzak EJ. The Impact of Blue Light Cystoscopy on the Diagnosis and Treatment of Bladder Cancer. Curr Urol Rep. 2017 May;18(5):39. doi: 10.1007/s11934-017-0685-8.</citation>
    <PMID>28324275</PMID>
  </reference>
  <reference>
    <citation>Torre LA, Bray F, Siegel RL, Ferlay J, Lortet-Tieulent J, Jemal A. Global cancer statistics, 2012. CA Cancer J Clin. 2015 Mar;65(2):87-108. doi: 10.3322/caac.21262. Epub 2015 Feb 4.</citation>
    <PMID>25651787</PMID>
  </reference>
  <verification_date>September 2019</verification_date>
  <study_first_submitted>August 30, 2017</study_first_submitted>
  <study_first_submitted_qc>September 1, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 5, 2017</study_first_posted>
  <last_update_submitted>September 17, 2019</last_update_submitted>
  <last_update_submitted_qc>September 17, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">September 18, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Sir Mortimer B. Davis - Jewish General Hospital</investigator_affiliation>
    <investigator_full_name>Dr. Te Vuong</investigator_full_name>
    <investigator_title>Director, Radiation Oncology Department</investigator_title>
  </responsible_party>
  <keyword>Fluorescence Sigmoidoscopy</keyword>
  <keyword>PDD</keyword>
  <keyword>Photodynamic Diagnosis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Colorectal Neoplasms</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/NCT03272659
org study id: 17-140
nct id: NCT03272659
lead sponsor: 
collaborator: 
is fda regulated drug: Yes
is fda regulated device: No
This will be a pilot study involving 5 patients diagnosed with colorectal carcinoma and
      treated with pre-operative chemotherapy and external beam radiation therapy at the Jewish
      General Hospital, whom will very soon undergo surgery. Participants will be sensitized by the
      instillation of a 250 mL enema containing 1.6 mmol of HAL. The enema will be administered
      with a plastic tube with an inflatable blocking balloon to prevent leakage of the enema.
      Fluorescence sigmoidoscopy will be performed with white light then blue excitation light
      after retention of the enema for 60 minutes, followed by a rest time of up to 30 minutes
      before rectoscopy. Red fluorescence should be induced by illumination with blue light.
      Pictures with and without fluorescence will be taken. The patients will undergo a colectomy
      (partial or complete) within the next 2-3 days and the surgical specimens will be collected
      for further fluorescence microscopy studies and pathological correlation of fluoresce with
      malignant pathology/histology as the gold standard. The total concentration of porphyrins in
      the patients' urine and serum will be recorded before sensitization, immediately after
      sensitization (instillation of the enema), and approximately 24 hours after sensitization.
      The patients' pre-and-post operative liver function tests will be measured. Adverse events
      will be reported by direct questioning of all patients with regards to photosensitivity and
      gastrointestinal symptoms (nausea, vomiting), and by measuring blood pressure and heart rate.
      Our objectives and endpoints are: 1) to determine if fluorescence with photodynamic
      diagnostics is selective for colorectal cancer, 2) to determine if photodynamic diagnostics
      has the potential to improve the detection of malignant cell after neoadjuvant chemotherapy
      and radiation, and 3) to determine if photodynamic diagnostics can provide an accurate
      depiction of the extent of disease burden not visible with normal white light sigmoidoscopy
      to the naked human eye.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: fluorescence with photodynamic diagnostics (PDD) in colorectal cancer
time frame: 9 months
description: To observe red fluorescence wirh PDD when lesions are illuminate with blue fluorescence during fluorescence sigmoidoscopy.
measure: Detect malignant lesions
time frame: 9 months
description: Using the images of fluorescence sigmoidoscopy, detect malignant lesions after neoadjuvant chemotherapy and radiation.
measure: Accurate depiction of the extent of disease burden by correlating pre-and post surgical results after neoadjuvant chemotherapy and radiation.
time frame: 9 months
arm group label: Blue Light Cystoscopy with Cysview®
arm group type: Experimental
description: The enema will be administered to participant. Fluorescence sigmoidoscopy will be performed with white light then blue excitation light after retention of the enema for 60 minutes, followed by a rest time of up to 30 minutes before rectoscopy.
Post-operative surgical specimens will be collected for further fluorescence microscopy studies and pathological correlation of fluoresce with malignant pathology/histology as the gold standard.
intervention type: Drug
intervention name: Cysview
description: 250 mL enema containing 1.6 mmol of hexaminolevulinate
arm group label: Blue Light Cystoscopy with Cysview®
other name: hexaminolevulinate
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
citation: Endlicher E, Gelbmann CM, Knuchel R, Furst A, Szeimies RM, Golder SK, Scholmerich J, Lottner C, Messmann H. Hexaminolevulinate-induced fluorescence endoscopy in patients with rectal adenoma and cancer: a pilot study. Gastrointest Endosc. 2004 Sep;60(3):449-54. doi: 10.1016/s0016-5107(04)01723-7.
PMID: 15332045
citation: Mayinger B, Neumann F, Kastner C, Degitz K, Hahn EG, Schwab D. Early detection of premalignant conditions in the colon by fluorescence endoscopy using local sensitization with hexaminolevulinate. Endoscopy. 2008 Feb;40(2):106-9. doi: 10.1055/s-2007-967019. Epub 2008 Jan 16.
PMID: 18197583
citation: Mayinger B, Neumann F, Kastner C, Haider T, Schwab D. Hexaminolevulinate-induced fluorescence colonoscopy versus white light endoscopy for diagnosis of neoplastic lesions in the colon. Endoscopy. 2010 Jan;42(1):28-33. doi: 10.1055/s-0029-1243804. Epub 2010 Jan 11.
PMID: 20066590
citation: Pietzak EJ. The Impact of Blue Light Cystoscopy on the Diagnosis and Treatment of Bladder Cancer. Curr Urol Rep. 2017 May;18(5):39. doi: 10.1007/s11934-017-0685-8.
PMID: 28324275
citation: Torre LA, Bray F, Siegel RL, Ferlay J, Lortet-Tieulent J, Jemal A. Global cancer statistics, 2012. CA Cancer J Clin. 2015 Mar;65(2):87-108. doi: 10.3322/caac.21262. Epub 2015 Feb 4.
PMID: 25651787
responsible party type: Sponsor-Investigator
investigator affiliation: Sir Mortimer B. Davis - Jewish General Hospital
investigator full name: Dr. Te Vuong
investigator title: Director, Radiation Oncology Department
mesh term: Colorectal Neoplasms