Not Yet RecruitingNot Applicable

Alpha Radiation Emitters Device for the Treatment of Primary and Recurrent Squamous Cell Carcinoma of the Vulva (DaRT).

10 participantsStarted 2024-04

Plain-language summary

A unique approach for cancer treatment employing intratumoral diffusing alpha radiation emitter device for the treatment of Primary and Recurrent Squamous Cell Carcinoma of the Vulva.

Who can participate

Age range18 Years – 120 Years

SexFEMALE

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Inclusion criteria

✓. Histologically confirmed newly diagnosed or recurrent (local) vulva SCC with or without distant metastases within 12 months
✓. Tumor size ≤ 7 centimeters in the longest diameter.
✓. Targeted lesion must be technically amenable for complete coverage (including margins) by the Alpha DaRT sources.
✓. Measurable target according to RECIST v1.1
✓. Interstitial implant indication validated by multidisciplinary team.
✓. ECOG Performance Status ≤3.
✓. Life expectancy ≥6 months.
✓. Women Age ≥18

Exclusion criteria

✕. Concomitant chemotherapy or immunotherapy within the past 4 weeks
✕. Fit for surgical exploration unless the patient refuses surgery
✕. Known hypersensitivity to any of the components of the treatment.
✕. Patients undergoing systemic immunosuppressive therapy excepting intermittent, brief use of systemic corticosteroids.
✕. Longest tumor diameter \>7 cm.
✕. 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.
✕. Patients with uncontrolled intercurrent illnesses including, but not limited to an active infection requiring systemic therapy (not including cholangitis) or a known psychiatric or substance abuse disorder(s) that would interfere with cooperation with the requirements of the trial or interfere with the study endpoints.
✕. Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer.

What they're measuring

Feasibility - DaRT seed placement

Timeframe: immediately following the insertion procedure

Safety - Adverse events

Timeframe: From day 0

Trial details

NCT IDNCT06202339

SponsorAlpha Tau Medical LTD.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-04

Contact for this trial

Liron Dimnik

+972542688602 LironD@alphatau.com

View on ClinicalTrials.gov More Carcinoma of the Vulva trials