An Open Dose-finding Study of Oral Applied Hexaminolevuli... | NCT01344902

Studies
An Open Dose-finding Study of Oral Applied Hexaminolevulinate (HAL) Imaging in Patients With Suspicion or High Risk of Neoplasia in the Colon

NCT01344902

Sponsor

Photocure

Status

Terminated

Last Update Posted

Oct 23, 2013Estimated

Enrollment

13Actual

Phase

Phase 1Phase 2

Conditions

Colon Cancer

Interventions

hexaminolevulinate HCl

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2013

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

The study was stopped due to inadequate efficacy after 13 patients were evaluated.

Expanded Access Info

Start Date

Feb 2009

Primary Completion Date

Oct 2009Actual

Completion Date

Not provided

First Submitted Date

Jan 14, 2010

First Submission Date that Met QC Criteria

Apr 28, 2011

First Posted Date

Apr 29, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 22, 2013

Last Update Posted Date

Oct 23, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Carcinoma of the lower GI-tract is among the leading malignancies in the western world causing a substantial morbidity, mortality and consequently a large burden to the health care system in the diagnosis, treatment and follow-up of these patients.

The primary objectives of this study is to determine carcinoma- and adenoma lesion true detection rate of HAL fluorescence colonoscopy in patients with known or strong suspicion of neoplasia in the colon. The secondary objective and endpoints are to determine carcinoma- and adenoma lesion false detection rate of HAL fluorescence colonoscopy, to compare carcinoma- and adenoma lesion true detection rates and the false detection rates of fluorescence with standard colonoscopy and to characterize the safety profile of HAL fluorescence colonoscopy.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

13Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Hexaminolevulinate	Experimental		Drug: hexaminolevulinate HCl

Interventions

Name	Type	Description	Arm Group Labels	Other Names
hexaminolevulinate HCl	Drug	200mg hexaminolevulinate HCl capsule 6 hours before colonoscopy	Hexaminolevulinate

Measure	Description	Time Frame
Determine the carcinoma- and adenoma lesion true detection rate		Baseline

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Known or strong suspected porphyria
Contraindications to colonoscopy

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Klinikum München Pasing		Munich		81241	Germany

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
18197583	Result	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.

ID	Term
D015179	Colorectal Neoplasms
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms