Assessment of Microvascular Alterations in Basal Cell Carcinoma Undergoing Bleomycin Electrochemotherapy or Photodynamic Therapy via Optical Coherence Tomography

Trial ID: 2024-518228-63-01
Sponsor: Zealand University Hospital

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Diseases & Conditions

Basal cell carcinoma

Objectives

The primary objective of this study is to investigate the **microvascular changes** in basal cell carcinoma (BCC) during non-surgical treatment using dynamic optical coherence tomography (D-OCT). Understanding these changes is clinically relevant as it may provide insights into the efficacy and mechanism of action of non-surgical therapies, such as electrochemotherapy and photodynamic therapy, in treating BCC. This could potentially lead to improved treatment strategies and outcomes for patients with this common form of skin cancer.

Secondary objectives include assessing any predictors in the clinical outcome of BCC undergoing non-surgical therapy by means of using D-OCT. Additionally, the study aims to evaluate the Quality of Life in patients undergoing these treatments. These secondary objectives are important for identifying factors that may influence treatment success and for understanding the broader impact of these therapies on patient well-being.

Participants

The clinical trial focuses on individuals diagnosed with **basal cell carcinoma**, specifically targeting low-risk cases located on the trunk and extremities with a diameter of less than 2 cm. The study population includes both male and female participants aged 18 years and older, with no specific upper age limit indicated. Participants are required to be in good general health, classified as ASA class I-III according to the American Society of Anesthesiology. The trial does not involve a vulnerable population. Participants must be mentally capable of understanding the study information and provide written informed consent. The trial does not specify the total number of participants, as this information was not provided by the sponsor. Lifestyle considerations such as diet, physical activity, or habits are not detailed in the available data. Key inclusion criteria include the absence of prior sensitivity or allergies to the treatment drug and agreement to undergo a punch biopsy at a 1-year follow-up. Women of non-childbearing potential and those of childbearing potential with a negative pregnancy test are eligible, provided they adhere to adequate contraception measures during and after the trial period.

Plans and Procedures

The clinical trial is designed to evaluate the **microvascular changes** in patients with **basal cell carcinoma** (BCC) undergoing non-surgical treatment using dynamic optical coherence tomography (D-OCT). This is a Phase 4, randomized, double-blind, controlled trial. The trial is expected to commence on January 1, 2025, and conclude by July 25, 2027. Participants will be randomly assigned to receive either electrochemotherapy or photodynamic therapy, with **bleomycin** as the active substance administered via cutaneous use. The primary endpoint is to assess the occlusion and reduction of patent vessels at various depths, while secondary endpoints include evaluating predictors of clinical outcomes, quality of life, and hyperpigmentation as a side effect.

The study will involve several visits, beginning with an inclusion (screening) visit to confirm eligibility based on criteria such as age, diagnosis, and medical history. Participants must provide written informed consent and meet specific inclusion criteria, including having a clinically diagnosed low-risk BCC on the trunk or extremities with a diameter of less than 2 cm. Follow-up visits will occur at specified intervals to monitor treatment effects and assess endpoints. The end-of-study visit will evaluate the overall treatment outcomes and any long-term effects.

Participant involvement is expected to last for the duration of the treatment period, with a maximum treatment period of one year. Conditions that may lead to early termination from the study include adverse reactions to the treatment, withdrawal of consent, or any significant protocol deviations. The trial aims to provide valuable insights into the efficacy and safety of non-surgical treatments for BCC, contributing to improved therapeutic strategies for this common skin cancer.

Treatment

The clinical trial involves the use of **bleomycin**, a glycopeptide antibiotic utilized as an antineoplastic agent. The pharmaceutical form of bleomycin is designated as PHF00231MIG. The medication is administered via **cutaneous use**. The maximum daily dose is set at 15,000 IU (international units), with a total maximum dose of 400,000 IU over the treatment period. The maximum treatment period is limited to one day. Bleomycin is not formulated specifically for pediatric use in this trial. The active substance is a mixture, and no synonyms or additional descriptive names are provided for the active substance.

Efficacy

Efficacy in this clinical trial will be assessed by evaluating the **microvascular changes** in Basal Cell Carcinoma (BCC) during non-surgical treatment using Dynamic Optical Coherence Tomography (D-OCT). The primary endpoint involves measuring the occlusion, specifically the diameter of the widest vessel at various depths (0, 150, 300, and 500 micrometers), and the reduction in the proportion of patent vessels. These measurements will be compared to pre-treatment and post-treatment levels during scheduled visits.

Secondary endpoints include assessing predictors such as thickness, density, attenuation, and vascular pattern in the clinical outcome of BCC undergoing non-surgical therapy. Additionally, the quality of life in patients will be evaluated using the Skin Cancer Quality of Life (SCQoL) instrument. The trial will also monitor hyperpigmentation as a side effect of the treatment with bleomycin. These assessments will provide comprehensive data on the efficacy of the treatment modalities being studied.

Inclusion and Exclusion Criteria

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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. 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.

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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”