Blood vessel changes in regular skin cancer undergoing either electrochemotherapy or conventional topical treatment assessed with optical coherence tomography

Phase 1

Conditions: Basal cell carcinoma in adults
MedDRA version: 20.0Level: LLTClassification code 10073093Term: Nodular basal cell carcinomaSystem Organ Class: 100000004864
MedDRA version: 20.0Level: LLTClassification code 10042503Term: Superficial basal cell carcinomaSystem Organ Class: 100000004864
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2017-000746-22-DK

Lead Sponsor: Department of Dermatology, Zealand University Hospital, Roskilde

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

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 < 2 cm..
4.Men or women aged at least 18 years.
5.Cases reviewed by a dermatological specialist.
6.ASA class I-III (Classification of the American Society of Anesthesiology)
7.No prior history of sensitivity or allergies to the chosen treatment drug.
8. A female of non-childbearing potential: (i.e. physiologically incapable of becoming pregnant)

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 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 55

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”