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

NCT03272659 | Withdrawn Phase 2 FDA Drug

• 1 other identifier: 17-140
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Colorectal Cancer; Photodynamic Diagnosis

Keywords

Fluorescence Sigmoidoscopy; PDD; Photodynamic Diagnosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Detect malignant lesions

  9 months

Other Outcomes (1)

• Accurate depiction of the extent of disease burden by correlating pre-and post surgical results after neoadjuvant chemotherapy and radiation.

  9 months

Study Arms (1)

Blue Light Cystoscopy with Cysview®

EXPERIMENTAL

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.

Drug: Cysview

Interventions

Cysview DRUG

250 mL enema containing 1.6 mmol of hexaminolevulinate

Also known as: hexaminolevulinate

Blue Light Cystoscopy with Cysview®

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients older than 18 years of age with diagnosed colorectal cancer.
• Colorectal cancer patients treated with Chemotherapy and external beam radiation therapy

You may not qualify if:

• \) Liver cirrhosis
• \) Acute or chronic hepatitis
• \) Elevated liver function tests of unknown etiology with elevation of transaminases of more than 3 times normal levels
• \) Known porphyria
• \) Pregnancy
• \) Expected lack of compliance

Sponsors & Collaborators

• Dr. Te Vuong: lead
• KARL STORZ Endoscopy-America, Inc.: collaborator

Related Publications (5)

• 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.

  PMID: 15332045 BACKGROUND

• 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.

  PMID: 18197583 BACKGROUND

• 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.

  PMID: 20066590 BACKGROUND

• 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.

  PMID: 28324275 BACKGROUND

• 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.

  PMID: 25651787 BACKGROUND

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

5-aminolevulinic acid hexyl ester

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director, Radiation Oncology Department

Study Record Dates

• First Submitted: August 30, 2017
• First Posted: September 5, 2017
• Study Start: April 1, 2018
• Primary Completion: December 1, 2018
• Study Completion: April 1, 2019
• Last Updated: September 18, 2019

Record last verified: 2019-09