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Recruitment Status : Withdrawn (Long process and due to strict deadline, project was stopped.)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
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer Photodynamic Diagnosis||Drug: Cysview||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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.
250 mL enema containing 1.6 mmol of hexaminolevulinate
Other Name: hexaminolevulinate
- 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.
- Detect malignant lesions [ Time Frame: 9 months ]Using the images of fluorescence sigmoidoscopy, detect malignant lesions after neoadjuvant chemotherapy and radiation.
- Accurate depiction of the extent of disease burden by correlating pre-and post surgical results after neoadjuvant chemotherapy and radiation. [ Time Frame: 9 months ]