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

Colorectal Cancer Clinical Trial

— PDD  

Official title:

The Correlation of Surgical Colorectal Cancer Specimen Pathology With the Fluorescence of Photodynamic Diagnostics (PDD): a Clinical Pilot Study

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03272659
• Other study ID #: 17-140
• Status: Withdrawn
• Phase: Phase 2
• Start date: April 1, 2018
• Est. completion date: April 1, 2019

Study information

• Verified date: September 2019
• Source: Sir Mortimer B. Davis - Jewish General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 1, 2019
• Est. primary completion date: December 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms
• Photodynamic Diagnosis

Intervention

Drug:
• Cysview
250 mL enema containing 1.6 mmol of hexaminolevulinate

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Dr. Te Vuong	KARL STORZ Endoscopy-America, Inc.

References & Publications (5)

Endlicher E, Gelbmann CM, Knüchel R, Fürst A, Szeimies RM, Gölder SK, Schölmerich 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. — View 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. — View 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. — View 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. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Accurate depiction of the extent of disease burden by correlating pre-and post surgical results after neoadjuvant chemotherapy and radiation.		9 months
Primary	fluorescence with photodynamic diagnostics (PDD) in colorectal cancer	To observe red fluorescence wirh PDD when lesions are illuminate with blue fluorescence during fluorescence sigmoidoscopy.	9 months
Secondary	Detect malignant lesions	Using the images of fluorescence sigmoidoscopy, detect malignant lesions after neoadjuvant chemotherapy and radiation.	9 months