Evaluation of the benefit of fluorescence diagnostics using Metvix® and the Dyaderm system for the preoperational estimation of the lateral tumour spread in basal cell carcinomas. - FD-BZK
- Conditions
- basal cell carcinomaMedDRA version: 9.1Level: PTClassification code 10004146Term: Basal cell carcinoma
- Registration Number
- EUCTR2007-004790-25-DE
- Lead Sponsor
- niversity of Leipzig
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Basal cell carcinoma, clinically or histologically ascertained
Size of tumor 0,5 to 1,5 cm
Age = 18 years
Written informed consent of the patient
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Other tumors
Basal cell carcinoma, pigmented subtype; sclerodermiform subtype
Patients suffering from porphyrie
Hypersensitivity to methyl(5-amino-4oxopentanoat)hydrochloride, any other component of the cream or peanut oil
Insufficient compliance
Women during pregnancy and lactation
Fertile women (< than two years after their last menstruation) without a highly effective method of birth control (defined as those which result in a low failure rate - i.e. less than 1% per year when used consistently and correctly - such as implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or vasectomised partner) during the clinical trial. For subjects using a hormonal contraceptive method, information regarding the product under evaluation and its potential effect on the contraceptive should be addressed.
Concurrent participation in other clinical trials
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method