Ignite Creation Date:
2025-12-24 @ 3:03 PM
Ignite Modification Date:
2026-02-20 @ 3:43 PM
Study NCT ID:
NCT03272659
Status:
WITHDRAWN
Last Update Posted:
2019-09-18
First Post:
2017-08-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Correlation of Surgical Colorectal Cancer Specimen Pathology With the Fluorescence of Photodynamic Diagnostics
Sponsor:
Dr. Te Vuong
Organization:
Study Overview
Official Title:
The Correlation of Surgical Colorectal Cancer Specimen Pathology With the Fluorescence of Photodynamic Diagnostics (PDD): a Clinical Pilot Study
Status:
WITHDRAWN
Status Verified Date:
2019-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Long process and due to strict deadline, project was stopped.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PDD
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: