NCT00285701

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for phase_1 colorectal-cancer

Timeline
Completed

Started Jul 2006

Shorter than P25 for phase_1 colorectal-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 31, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 2, 2006

Completed
5 months until next milestone

Study Start

First participant enrolled

July 1, 2006

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2007

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed
Last Updated

January 15, 2010

Status Verified

January 1, 2010

Enrollment Period

1.3 years

First QC Date

January 31, 2006

Last Update Submit

January 14, 2010

Conditions

Colorectal Cancer

Interventions

hexaminolevulinateDRUG

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with suspicion of colorectal cancer
  • Written informed consent
  • Data protection consent
  • years

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept of Medicine, Munic-Hospital Pasing

Munich, Bavaria, Germany

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

5-aminolevulinic acid hexyl ester

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 31, 2006

First Posted

February 2, 2006

Study Start

July 1, 2006

Primary Completion

November 1, 2007

Study Completion

March 1, 2008

Last Updated

January 15, 2010

Record last verified: 2010-01

Locations

DE(1)