Blood vessel changes in regular skin cancer undergoing either electrochemotherapy or photodynamic therapy assessed with optical coherence tomography

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Region Sjaelland

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Skin and Connective Tissue Diseases [C17]

Trial duration

completed 27 Jun 2025

Decision date (initial)

2024-11-25

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Region Sjællands Sundhedsvidenskabelige Fond Zealand · Den Bøhmske Fond · Department of Dermatology, Zealand University Hospital, Roskilde

External identifiers

EU CT number

2024-518228-63-01

EudraCT number

2017-000746-22

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Others

The primary objective is to investigate the microvascular changes in Basal cell carcinoma during non-surgical treatment using D-OCT.

Secondary objectives 1

1. 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

Conditions and MedDRA coding

basal cell carcinoma

Regulatory references

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 1

1. 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.

Exclusion criteria 1

1. 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”

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. 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.

Secondary endpoints 1

1. 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

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Region Sjaelland

Sponsor organisation

Region Sjaelland

Address

Sygehusvej 10

City

Roskilde

Postcode

4000

Country

Denmark

Scientific contact point

Organisation

Region Sjaelland

Contact name

Gabrielle Vinding

Public contact point

Organisation

Region Sjaelland

Contact name

Gregor Jemec

Third parties 1

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 7 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications