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Phase 1/Phase 2
18 Years
80 Years
Open (Enrolling)
Both
Colon Cancer

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Trial Information


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Determine the carcinoma- and adenoma lesion true detection rate

Outcome Time Frame:

Baseline

Safety Issue:

No

Authority:

Germany: Federal Institute for Drugs and Medical Devices

Study ID:

PC CO201/08

NCT ID:

NCT01344902

Start Date:

February 2009

Completion Date:

Related Keywords:

  • Colon Cancer
  • Colonic Neoplasms

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