basal cell carcinoma MedDRA version: 9.1 Level: PT Classification code 10004146 Term: Basal cell carcinoma
Conditions
Interventions
Trade Name: Metvix®
Product Name: Metvix®
Pharmaceutical Form: Cream
INN or Proposed INN: Methyl(5-amino-4-oxopentanoat) as hydrochloride
Current Sponsor code: Metvix®
Concentration unit: mg/g milligr
Sponsors
University of Leipzig
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): Determination of an indicator for the incremental benefit of fluorescence diagnostics (FD). II = 1, if the tumor is fully contained within the area defined by FD and clinical diagnostics (CD), but not within the area defined by CD alone, II = 0 otherwise. ;Main Objective: The clinical trial is intended to evaluate the use of fluorescence diagnostics using Metvix und Dyaderm for the determination of the lateral extension of basal cell carcinomas.;Secondary Objective: It will be analyzed whether tumor resection based on fluorescence diagnostics reduces the number of necessary re-excisions in comparison to exclusively optical evaluation of the lateral tumor extension. | — |
Countries
Germany
Outcome results
None listed