E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10004146 |
E.1.2 | Term | Basal cell carcinoma |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
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E.2.2 | Secondary objectives of the trial |
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. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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
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E.4 | Principal 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 |
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E.5 End points |
E.5.1 | 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.
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Yes |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | Information not present in EudraCT |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 4 |
E.8.9.1 | In the Member State concerned days | |