Alpha Radiation Emitters Device (DaRT) for the Treatment of Cutaneous SCC for Immunocompromised Patients

Recruiting now · Not applicable

Conditions studied: Squamous Cell Carcinoma, Alpha Radiation, Immunocompromised, Carcinoma, Squamous, Skin Cancer, Brachytherapy

In brief

This is a multi-center clinical study enrolling up to 28 participants. The primary objectives are to determine the objective response rate (ORR) established by the confirmed best overall response (BOR) following intratumoral administration of DaRT - Diffusing Alpha-Emitters Radiation Therapy. Secondary objectives are to: 1. Determine Progression Free Survival (PFS) up to 12 months after Alpha DaRT sources insertion. 2. Assess Overall Survival (OS) of patients treated with DaRT up to 12 months. 3. Assess Local control up to 12 months after DaRT insertion.

Key facts

Study ID

NCT06615635

Run by

Alpha Tau Medical LTD.

People needed

28

Starts

2026-01-01

Expected to finish

2026-12-01

Last updated by the study team

2026-07-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 1. Patients with cutaneous SCC histologically confirmed 2. Histopathological confirmation within 6 months of enrollment provided no tumor treatment occurred between the biopsy and enrollment 3. Immunocompromised due to any primary or secondary immunodeficiencies Measurable disease according to RECIST v 1.1.
• Patient able and willing to undergo multiple CT scans 5. Tumor size ≤7 cm, at the longest diameter. 6. Single lesion per subject. 7. Targeted lesion must be technically amenable for complete coverage (including margins) by the DaRT seeds. Targets will be deemed technically amenable for complete coverage if there are entry and exit vectors for placement that are not hindered by bone or major vessels or other vital organs (eg. eye) as decided by treating physician and sponsor.
• Interstitial implant indication validated by multidisciplinary team. 9. ECOG Performance Status ≤2. 10. Life expectancy ≥12 months. 11. Subjects male/ female ≥18. 12. Willing and have the ability to provide signed Informed Consent. 13. Patients, male and female, with reproductive potential (including women who are menopausal for less than a year and not surgically sterilized), must practice acceptable effective methods of birth control, such as barrier methods, condom or diaphragm with spermicide or abstinence. Birth control should be continued for 1 year after the DaRT insertion visit.
• Women with childbearing potential must provide a negative pregnancy test during the screening period and up to V1, prior to the DaRT insertion procedure.
• Blood tests values:
• Platelets ≥100,000 mm3,
• Total bilirubin ≤ 1.5xULN,
• AST ≤2.5xULN,
• SGOT ≤2.5xULN,
• SGPT ≤2.5xULN,
• Alkaline Phosphatase ≤2.5xULN.
• Creatinine Clearance ≥30 ml/min.
• INR or Prothrombin time ≤1.5xULN.

You may not qualify if…

• 1. Distant or nodal metastatic disease (according to the TNM staging system - N+ or M1 patients are excluded).
• T4 disease 3. extensive PNI 4. Previously untreated cutaneous SCC 5. Mucosal SCC. 6. Inability to fully cover the entire volume with DaRT seeds 7. Inability to place DaRT seeds into tumor due to inaccessibility by presence of bones or major vessels or vital organs 8. Inability or unwillingness to undergo multiple CT scans 9. Patients receiving any of the following within 4 weeks of enrollment:
• Antineoplastic systemic chemotherapy or biological therapy
• Immunotherapy
• Investigational agents other than the study intervention
• Radiation therapy
• Live vaccines within 30 days prior to the first dose of trial treatment and while participating in the trial.
• Longest tumor diameter >7 cm. 11. Tumor with keratoacanthoma histology. 12. Known hypersensitivity to any component of treatment. 13. Clinically significant cardiovascular disease e.g., cardiac failure of New York Heart Association class III-IV, uncontrolled coronary artery disease, cardiomyopathy, uncontrolled arrhythmia, uncontrolled hypertension, 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 treatment and to adhere to the clinical trial protocol.
• Serious medical comorbidities that, in the opinion of the investigator, may affect subject compliance and/or interpretation of treatment safety or effectiveness.
• High probability of protocol non-compliance (in opinion of investigator). 17. 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.
• Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer.
• Patients do not agree to use adequate contraception (vasectomy or barrier method of birth control) prior to study entry and for 1 year after the DaRT insertion visit.
• Breastfeeding or pregnant women 21. Tattoos scars, body jewelry (e.g., nose rings) or other identifying marks which cannot be adequately hidden on digital photos or other identifying marks which cannot be adequately hidden on digital photos

Where it is running

• Us Dermatology Parthners — Phoenix, Arizona, United States (enrolling)
• Emory University — Atlanta, Georgia, United States (enrolling)
• Hollywood Dermatology — Hollywood, Florida, United States (enrolling)
• Bassett Healthcare — Cooperstown, New York, United States (enrolling)
• Banner Health — Gilbert, Arizona, United States (enrolling)
• Alliance Dermatology — Phoenix, Arizona, United States (enrolling)
• Hadassah Medical Center — Jerusalem, Israel
• Integrity Research Clinical Associates — Boca Raton, Florida, United States
• Palm Beach Dermatology Group — Palm Beach, Florida, United States
• Day Star Skin Cancer Center — Poinciana, Florida, United States
• Mayo Clinic — Rochester, Minnesota, United States

Full record on ClinicalTrials.gov

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