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Blood vessel changes in regular skin cancer undergoing either electrochemotherapy or photodynamic therapy assessed with optical coherence tomography
EU CTIS ID: 2024-518228-63-01
What this study is testing
The primary objective is to investigate the microvascular changes in Basal cell carcinoma during non-surgical treatment using D-OCT.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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. Patients must initially agree to have a punhbiopsy performed at 1-year follow-up 9. A female of non-childbearing potential: (i.e.i.e., physiologically incapable of becoming pregnant) is eligible in the study if she: • Has had a hysterectomy. • Has had a bilateral oophorectomy (ovariotomy). • Has had a bilateral tuba ligation. • Is post menopausalpost-menopausal: Post menopausalPost-menopausal definition: Patients not using hormone replacement must have experienced total cassation of menses for one year and be greater than 45 years in age, or, in questionable cases have a follicle stimulation hormone (FSH) value 40 mIU/mL and an estradiol value 40 pg/mL (<140 pmol/L). Patients using Hormone Replacement Therapy must have experienced total cessation of menses > 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.
You likely can't join if
- 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”
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.