The Correlation of Surgical Colorectal Cancer Specimen Pathology With the Fluorescence of Photodynamic Diagnostics
Status:
Withdrawn
Trial end date:
2019-04-01
Target enrollment:
Participant gender:
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.