Early Detection of Polyps and Colon Cancer by Fluorescence Imaging

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-07-31

Study Completion Date

2008-03-31

Brief Summary

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Patients referred for colon inspection (colonoscopy) due to suspicion of colon polyps/cancer will receive local administration of hexaminolevulinate (HAL) prior to colon inspection. Blue light illumination will induce red fluorescence of polyps and tumours, improving detection of the polyps and tumors. Different HAL doses will be tested to find the optimal image conditions. Tolerability measurements will be performed to ensure patient safety.

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Detailed Description

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Colonoscopy is regarded as the "gold standard" for diagnosis of colorectal cancer. The sensitivity is uncertain but proposed to be (75-95%), however flat adenomas which are easily missed, are often not recognised. Fluorescence imaging may increase the sensitivity of standard white light colonoscopy by identifying more polyps and flat adenomas which will make the resection of adenomas more complete.

In this study hexaminolevulinate (HAL) will be administered locally as a photosensitiser, using different doses to find the optimal imaging conditions as well as making patient safety assessments.

Both standard white light and blue light (fluorescence) inspection will be performed.

Conditions

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Colorectal Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Interventions

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hexaminolevulinate

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients with suspicion of colorectal cancer
* Written informed consent
* Data protection consent
* 18-85 years

Exclusion Criteria

* Liver cirrhosis
* Hepatitis
* Abnormal liver function
* Porphyria
* Patient non-compliance
* Coagulation disorder
* Contraindication to colonoscopy
* Pregnancy and lactation
* Participation in another study

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Brigitte Mayinger, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Endlicher E, et al. Hexaminolevulinate-induced fluorescence endoscopy in patients with rectal adenoma and cancer: a pilot study. Gastrointestinal Endoscopy 2004;60:449-454