The Correlation of Surgical Colorectal Cancer Specimen Pathology With the Fluorescence of Photodynamic Diagnostics (PDD)
Primary Purpose
Colorectal Cancer, Photodynamic Diagnosis
Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Cysview
Sponsored by
About this trial
This is an interventional diagnostic trial for Colorectal Cancer focused on measuring Fluorescence Sigmoidoscopy, PDD, Photodynamic Diagnosis
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Blue Light Cystoscopy with Cysview®
Arm 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.
Outcomes
Primary Outcome Measures
fluorescence with photodynamic diagnostics (PDD) in colorectal cancer
To observe red fluorescence wirh PDD when lesions are illuminate with blue fluorescence during fluorescence sigmoidoscopy.
Secondary Outcome Measures
Detect malignant lesions
Using the images of fluorescence sigmoidoscopy, detect malignant lesions after neoadjuvant chemotherapy and radiation.
Full Information
NCT ID
NCT03272659
First Posted
August 30, 2017
Last Updated
September 17, 2019
Sponsor
Dr. Te Vuong
Collaborators
KARL STORZ Endoscopy-America, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT03272659
Brief Title
The Correlation of Surgical Colorectal Cancer Specimen Pathology With the Fluorescence of Photodynamic Diagnostics
Acronym
PDD
Official Title
The Correlation of Surgical Colorectal Cancer Specimen Pathology With the Fluorescence of Photodynamic Diagnostics (PDD): a Clinical Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Withdrawn
Why Stopped
Long process and due to strict deadline, project was stopped.
Study Start Date
April 1, 2018 (Anticipated)
Primary Completion Date
December 1, 2018 (Anticipated)
Study Completion Date
April 1, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Dr. Te Vuong
Collaborators
KARL STORZ Endoscopy-America, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer, Photodynamic Diagnosis
Keywords
Fluorescence Sigmoidoscopy, PDD, Photodynamic Diagnosis
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Blue Light Cystoscopy with Cysview®
Arm Type
Experimental
Arm 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(s)
Cysview
Other Intervention Name(s)
hexaminolevulinate
Intervention Description
250 mL enema containing 1.6 mmol of hexaminolevulinate
Primary Outcome Measure Information:
Title
fluorescence with photodynamic diagnostics (PDD) in colorectal cancer
Description
To observe red fluorescence wirh PDD when lesions are illuminate with blue fluorescence during fluorescence sigmoidoscopy.
Time Frame
9 months
Secondary Outcome Measure Information:
Title
Detect malignant lesions
Description
Using the images of fluorescence sigmoidoscopy, detect malignant lesions after neoadjuvant chemotherapy and radiation.
Time Frame
9 months
Other Pre-specified Outcome Measures:
Title
Accurate depiction of the extent of disease burden by correlating pre-and post surgical results after neoadjuvant chemotherapy and radiation.
Time Frame
9 months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
12. IPD Sharing Statement
Citations:
PubMed Identifier
15332045
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.
Results Reference
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PubMed Identifier
18197583
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.
Results Reference
background
PubMed Identifier
20066590
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.
Results Reference
background
PubMed Identifier
28324275
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.
Results Reference
background
PubMed Identifier
25651787
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.
Results Reference
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The Correlation of Surgical Colorectal Cancer Specimen Pathology With the Fluorescence of Photodynamic Diagnostics
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