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Early Detection of Polyps and Colon Cancer by Fluorescence Imaging - a Dose-finding Study

NCT00285701 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2010-01-15

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

hexaminolevulinate

Sponsors & Collaborators

  • KARL STORZ Endoscopy-America, Inc.

    collaborator INDUSTRY

  • Photocure

    lead INDUSTRY

Principal Investigators

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

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-07-31
Primary Completion
2007-11-30
Completion
2008-03-31

Countries

  • Germany

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00285701 on ClinicalTrials.gov