NCT01344902

Brief Summary

The purpose of the study is to determine if it is possible to detect more pre-cancerous lesions in colon when using fluorescence technology.

Trial Health

35
At Risk

Trial Health Score

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

Enrollment
13

participants targeted

Target at below P25 for phase_1

Geographic Reach
1 country

1 active site

Status
terminated

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

Study Start

First participant enrolled

February 1, 2009

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 14, 2010

Completed
1.3 years until next milestone

First Posted

Study publicly available on registry

April 29, 2011

Completed
Last Updated

October 23, 2013

Status Verified

October 1, 2013

Enrollment Period

8 months

First QC Date

January 14, 2010

Last Update Submit

October 22, 2013

Conditions

Colon Cancer

Outcome Measures

Primary Outcomes (1)

  • Determine the carcinoma- and adenoma lesion true detection rate

    Baseline

Study Arms (1)

Hexaminolevulinate

EXPERIMENTAL
Drug: hexaminolevulinate HCl

Interventions

hexaminolevulinate HClDRUG

200mg hexaminolevulinate HCl capsule 6 hours before colonoscopy

Hexaminolevulinate

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Female and Male subjects with known or strong suspicion iof adenoma or carcinoma of the colon after screening of follow-up colonoscopy
  • Female and male patients with verified neoplastic lesions

You may not qualify if:

  • Known or strong suspected porphyria
  • Contraindications to colonoscopy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Klinikum München Pasing

Munich, 81241, Germany

Location

Related Publications (1)

  • 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: 18197583RESULT

MeSH Terms

Conditions

Colonic Neoplasms

Interventions

5-aminolevulinic acid hexyl ester

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal Diseases

Study Design

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

Study Record Dates

First Submitted

January 14, 2010

First Posted

April 29, 2011

Study Start

February 1, 2009

Primary Completion

October 1, 2009

Last Updated

October 23, 2013

Record last verified: 2013-10

Locations

DE(1)