Treatment of skin and soft tissue cancers using alpha radiation emitters
A Safety and Preliminary Effectiveness Study of Intratumoral Diffusing Alpha Radiation Emitters on Cutaneous, Mucosal and Superficial Soft Tissue Neoplasia
This study is testing a new treatment that uses tiny radioactive seeds inserted into skin and soft tissue cancers to see if it can shrink tumors safely.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 35 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Alpha Tau Medical LTD. Industry-sponsored |
| Drugs / interventions | radiation |
| Locations | 1 site (Rome, Lazio) |
| Trial ID | NCT03886181 on ClinicalTrials.gov |
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 aims to reduce tumor volume and increase necrotic tissue. The study will assess outcomes 30-45 days after the insertion and removal of the seeds, focusing on both tumor response and safety through monitoring adverse events. It is a prospective, open-label, single-arm controlled study.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 with histopathologically confirmed superficial malignant tumors measuring 5 cm or less.
Not a fit: Patients with larger tumors, poor performance status, or specific histological types like Keratoacanthoma may not benefit from this treatment.
Why it matters
Potential benefit: If successful, this treatment could provide a targeted and effective option for patients with superficial skin and soft tissue cancers.
How similar studies have performed: While this approach is innovative, similar studies using localized radiation therapies have shown promise in treating superficial tumors.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Subjects with histopathological confirmation of cutaneous and/or mucosal and/or superficial soft tissue malignant neoplasia. * Subjects with a tumor size ≤ 5 centimeters in the longest diameter. * Subjects' age is over 18 years old. * Subjects' ECOG Performance Status Scale is \< 2. * Subjects' life expectancy is more than 6 months. * Women of childbearing potential (WOCBP) will have evidence of negative pregnancy test. * Subjects are able and willing to sign an informed consent form. Exclusion Criteria: * Subject has a tumor with a maximal diameter \> 5 centimeters. * Subjects' ECOG Performance Status Scale is \> 3. * Subject has a tumor of Keratoacanthoma histology. * Patients with moribund diseases, e.g., autoimmune diseases, vasculitis, etc. * Patients under systemic immunosuppressive and/or corticosteroid treatment. Patients taking corticosteroid inhalers are eligible.
Where this trial is running
Rome, Lazio
- IRCCS Istituto Dermatologico S. Gallicano, IFO - Istituti Fisioterapici Ospitalieri - Dermatologia Oncologica e Prevenzione — Rome, Lazio, Italy (Recruiting)
Study contacts
- Principal investigator: Laura Eibenschuz, MD — IFO S. Gallicano
- Study coordinator: Liron Dimnik
- Email: LironD@alphatau.com
- Phone: +972-2-373-7000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.