Treatment of skin and soft tissue cancers using alpha radiation emitters

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the safety and efficacy of a novel treatment method using diffusing alpha radiation emitters (DaRT) for patients with superficial cutaneous, mucosal, or soft tissue neoplasia. The approach involves inserting radioactive seeds directly into the tumor, allowing for localized radiation therapy that targets cancer cells while minimizing exposure to surrounding healthy tissue. The study will assess tumor size reduction 70 days post-treatment and monitor adverse events to evaluate safety. Participants must have confirmed malignancies and meet specific health criteria.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Subjects with histopathological confirmation of primary or secondary malignant cutaneous neoplastic lesions, or oral cavity mucosal tumors, or superficial soft tissue sarcoma. Confirmation obtained within 6 months of planned treatment.
* Subjects with a tumor size ≤ 7 centimeters in the longest diameter.
* Targetable lesion must be technically amenable for complete coverage (including margins) by the DaRT seeds
* Brachytherapy indication validated by a multidisciplinary team
* Patients who have either failed first-line treatment, or are medically unfit for standard of care (surgery, external-beam radiation therapy or chemotherapy), or refuse standard of care.
* Measurable disease according to RECIST v1.1.
* Subjects over 18 years old.
* Subjects' ECOG Performance Status Scale is \< 2.
* Subjects' life expectancy is more than 6 months.
* Platelet count ≥100,000/mm3.
* WBC ≥ 3500/μl, granulocyte ≥ 1500/μl
* AST and ALT ≤ 2.5 X ULN
* International normalized ratio of prothrombin time ≤1.8.
* Creatinine ≤1.9 mg/dL. Women of childbearing potential (WOCBP) will have evidence of negative pregnancy test and are required to use an acceptable contraceptive method to prevent pregnancy for 3 months after brachytherapy.
* Subjects are willing to sign an informed consent form.

Exclusion Criteria:

* Subject has a tumor of Keratoacanthoma histology.
* Known hypersensitivity to any of the components of the treatment.
* Clinically significant cardiovascular disease, e.g. cardiac failure of New York Heart Association classes III-IV, uncontrolled coronary artery disease, cardiomyopathy, uncontrolled arrhythmia, uncontrolled hypertension, or history of myocardial infarction in the last 12 months.
* Any medical or psychiatric illness which in the opinion of the investigator would compromise the patient's ability to tolerate this treatment or interfere with the study endpoints.
* Patients undergoing systemic immunosuppressive therapy excepting intermittent, brief use of systemic corticosteroids
* Patient requires treatment which may conflict with the endpoints of this study including evaluation of response or toxicity of DaRT
* Volunteers participating in another interventional study in the past 30 days which might conflict with the endpoints of this study or the evaluation of response or toxicity of DaRT.
* Patients must agree to use adequate contraception (vasectomy or barrier method of birth control) prior to study entry, for the duration of study participation and for 3 months after discontinuing therapy.
* High probability of protocol non-compliance (in opinion of investigator).
* Subjects not willing to sign an informed consent.
* Women who are pregnant or breastfeeding.

Where it's running

• Sharett institute, Hadassah Medical Center - Ein-Kerem
  Jerusalem, Israel Recruiting

Study contacts

• Principal investigator: Aron Popovtzer — Sharett institute, Hadassah University Hospital - Ein-Kerem
• Study coordinator: Liron Dimnik
• Email: LironD@alphatau.com
• Phone: +972-2-373-7000

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.