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The Correlation of Surgical Colorectal Cancer Specimen Pathology With the Fluorescence of Photodynamic Diagnostics (PDD)

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ClinicalTrials.gov Identifier: NCT03272659
Recruitment Status : Withdrawn (Long process and due to strict deadline, project was stopped.)
First Posted : September 5, 2017
Last Update Posted : September 5, 2018
Sponsor:
Collaborator:
KARL STORZ Endoscopy-America, Inc.
Information provided by (Responsible Party):
Dr. Te Vuong, Sir Mortimer B. Davis - Jewish General Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Photodynamic Diagnosis Drug: Cysview Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: The Correlation of Surgical Colorectal Cancer Specimen Pathology With the Fluorescence of Photodynamic Diagnostics (PDD): a Clinical Pilot Study
Estimated Study Start Date : April 1, 2018
Estimated Primary Completion Date : December 1, 2018
Estimated Study Completion Date : April 1, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Blue Light Cystoscopy with Cysview®

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.

Drug: Cysview
250 mL enema containing 1.6 mmol of hexaminolevulinate
Other Name: hexaminolevulinate




Primary Outcome Measures :
  1. fluorescence with photodynamic diagnostics (PDD) in colorectal cancer [ Time Frame: 9 months ]
    To observe red fluorescence wirh PDD when lesions are illuminate with blue fluorescence during fluorescence sigmoidoscopy.


Secondary Outcome Measures :
  1. Detect malignant lesions [ Time Frame: 9 months ]
    Using the images of fluorescence sigmoidoscopy, detect malignant lesions after neoadjuvant chemotherapy and radiation.


Other Outcome Measures:
  1. Accurate depiction of the extent of disease burden by correlating pre-and post surgical results after neoadjuvant chemotherapy and radiation. [ Time Frame: 9 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients older than 18 years of age with diagnosed colorectal cancer.
  • Colorectal cancer patients treated with Chemotherapy and external beam radiation therapy

Exclusion Criteria:

  • 1) Liver cirrhosis
  • 2) Acute or chronic hepatitis
  • 3) Elevated liver function tests of unknown etiology with elevation of transaminases of more than 3 times normal levels
  • 4) Known porphyria
  • 5) Pregnancy
  • 6) Expected lack of compliance

Publications:
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Responsible Party: Dr. Te Vuong, Director, Radiation Oncology Department, Sir Mortimer B. Davis - Jewish General Hospital
ClinicalTrials.gov Identifier: NCT03272659     History of Changes
Other Study ID Numbers: 17-140
First Posted: September 5, 2017    Key Record Dates
Last Update Posted: September 5, 2018
Last Verified: September 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Dr. Te Vuong, Sir Mortimer B. Davis - Jewish General Hospital:
Fluorescence Sigmoidoscopy
PDD
Photodynamic Diagnosis

Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases