Basal cell carcinoma in adults
Conditions
Interventions
Trade Name: Bleomycin "Baxter"
Pharmaceutical Form: Powder for solution for injection/infusion
Sponsors
Department of Dermatology, Zealand University Hospital, Roskilde
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: General inclusion criteria: 1. Patients must be mentally capable of understanding the information given. 2. Patients must give written informed consent. 3. Clinically diagnosed low-risk BCC on the trunk and ekstremities, diameter 1 year and be greater than 45 years of age or have had documented evidence of menopause based on FSH and estradiol concentrations prior to Hormone replacement therapy. 10 A female of childbearing potential: is eligible in the study only if she has had a negative serum or urine pregnancy test within 2 weeks prior to the electroporation treatment. 11 A woman of childbearing potential and men: Are eligible upon agreement to use adequate contraception since signing the informed consent form until at least 6 months after the last electroporation therapy cycle. The investigator or designated associate is requested to advise the patient how to achieve adequate birth control. 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 28 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 28
Exclusion criteria
Exclusion criteria: Exclusion criteria for ECT-treatment 1. Coagulation disorder or anticoagulant treatment with INR >1.5. 2. Platelets <70000/mm3 3. Cardiac history with manifest cardiac arrhythmia or previous cardiac events in patients with BCC on the anterior chest wall. 4. Patients with ICD or pacemaker units with BCC on the anterior chest wall. 5. Patients with epilepsy. 6. Pregnancy or lactation/breastfeeding. 7. Patients with known Hepatitis B/C or HIV infection. 8. Concurrent treatment with an investigational medicinal product. 9. Patients with any other clinical condition or prior therapy that, in the opinion of the investigator, would make the patient unsuitable for the study or unable to comply with the study recruitments. 10. Patients with Contraindications for bleomycin: • Acute pulmonary infection. • Medical history of severe pulmonary disease. • Previous allergic reactions to bleomycin. • Previous cumulative dose of bleomycin exceeding 400 000 IU/m2. 11. Patients registered in the Danish “Vævsanvendelsesregister”
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to investigate the microvascular changes in BCC during non-surgical treatment using D-OCT. The principally different mechanisms of action with either MAL-PDT or electrochemotharpy will be compared to each other by means of D-OCT.;Secondary Objective: To assess any predictors in clinical outcome of BCC undergoing non-surgical therapy by means of using D-OCT, futhermore to evaluate the Quality of Life in patients undergoing these treatments.;Primary end point(s): The primary objective is to investigate the microvascular changes in BCC during non-surgical treatment using D-OCT. The occlusion (diameter of the widest vessel at a given depth), reduction of the proportion of patent vessels at 0, 150, 300 and 500 micrometer depth will be assessed relative to pre-treatment and posttreatment levels according to visits. ;Timepoint(s) of evaluation of this end point: 30 minuttes after treatment, 1 day, 1 week, 3 months and one year | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): To assess any predictors (thickness, density, attenuation and vascular pattern) in clinical outcome of of BCC undergoing non-surgical therapy by means of using D-OCT. To evaluate the quality of life in patients undergoing these treatments by SCQoL. To evaluate hyperpigmentation as a side effect of bleomycin;Timepoint(s) of evaluation of this end point: 30 minuttes after treatment, 1 day, 1 week, 3 months and one year | — |
Countries
Denmark
Contacts
Public ContactDepartment
Department of Dermatology, Zealand University Hospital, Roskilde
Outcome results
None listed