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

July 14, 2026 updated by: Alpha Tau Medical LTD.

A Single Arm, Open Label Clinical Study to Assess the Safety and Efficacy of Intratumoral Alpha DaRT224 for the Treatment of Immunocompromised Patients With Cutaneous Squamous Cell Carcinoma

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This study is a multicenter, single arm, open label clinical study to assess the efficacy and safety of intratumoral Alpha DaRT-224 for the treatment of of Immunocompromised Patients with Cutaneous Squamous Cell Carcinoma

The "Diffusing Alpha-emitter Radiation Therapy (DaRT)", based on the intratumoral placement of an encapsulated Radium-224 source (3.7 days half-life), is described in this study. These sources release short-lived alpha-emitting atoms into the tumor microenvironment by recoil. Alpha DaRT sources will be inserted into Cutaneous Squamous Cell Carcinoma tumors and will be removed following 14-21 days.

The The objective response rate (ORR), which is calculated as the percent of patients achieving an objective response. Best overall response using the Response Evaluation Criteria in Solid Tumors guidelines (RECIST v1.1). Best overall response is assessed starting from DaRT removal. Safety will be assessed based on the cumulative incidence rate, severity and outcome of device related Adverse Events (AEs). Classification of AEs will be done according to CTCAE v5.

Study Type

Interventional

Enrollment (Estimated)

28

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Israel
      • Jerusalem, Israel, 9112001
  • United States
    • Arizona
      • Gilbert, Arizona, United States, 35234
      • Phoenix, Arizona, United States, 85032
        • Recruiting
        • Alliance Dermatology
        • Contact:
      • Phoenix, Arizona, United States, 85006
    • Florida
      • Boca Raton, Florida, United States, 33445
      • Hollywood, Florida, United States, 33201
      • Palm Beach, Florida, United States, 33848
        • Not yet recruiting
        • Palm Beach Dermatology Group
        • Contact:
      • Poinciana, Florida, United States, 33445
    • Georgia
      • Atlanta, Georgia, United States, 30308
        • Recruiting
        • Emory University
        • Contact:
        • Contact:
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Not yet recruiting
        • Mayo Clinic
        • Contact:
    • New York

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

    4. 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.

    8. 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.

    14. Women with childbearing potential must provide a negative pregnancy test during the screening period and up to V1, prior to the DaRT insertion procedure.

    15. 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.

Exclusion Criteria:

  • 1. Distant or nodal metastatic disease (according to the TNM staging system - N+ or M1 patients are excluded).

    2. 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:

    1. Antineoplastic systemic chemotherapy or biological therapy
    2. Immunotherapy
    3. Investigational agents other than the study intervention
    4. Radiation therapy

    5. Live vaccines within 30 days prior to the first dose of trial treatment and while participating in the trial.

      10. 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.

      14. 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.

      15. Serious medical comorbidities that, in the opinion of the investigator, may affect subject compliance and/or interpretation of treatment safety or effectiveness.

      16. 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.

      18. 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.

      19. 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.

      20. 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: DaRT seeds
Diffusing Alpha emitters Radiation (DaRT) treatment to be delivered through radioactive sources inserted into malignant cutaneous squamous cell carcinoma of Immunocompromised Patients
Device: DaRT seeds
Diffusing Alpha emitters Radiation (DaRT) treatment to be delivered through radioactive sources inserted into malignant cutaneous squamous cell carcinoma of Immunocompromised Patients
Other Names:
  • DaRT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
objective response rate
Time Frame: From Day 14 until 52 weeks
• Assessment of the objective response rate (ORR) determined by the best overall response using the Response Evaluation Criteria in Solid Tumors (RECIST) (Version 1.1).
From Day 14 until 52 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression Free Survival
Time Frame: Up to 12 months after DaRT seed insertion
• Determine Progression Free Survival (PFS) up to 12 months after DaRT seed insertion.
Up to 12 months after DaRT seed insertion
Overall Survival
Time Frame: Up to 12 months after DaRT seed insertion
• Assess Overall Survival (OS) of patients treated with DaRT up to 12 months.
Up to 12 months after DaRT seed insertion
Local control
Time Frame: Up to 12 months after DaRT seed insertion
• Assess Local control up to 12 months after DaRT insertion.
Up to 12 months after DaRT seed insertion

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety Objectives
Time Frame: Up to 12 months following DaRT insertion
Assess the safety of the Alpha DaRT treatment, based on the cumulative incidence rate, severity and outcome of device related AEs. Classification of AEs will be done according to CTCAE v5.
Up to 12 months following DaRT insertion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alpha Tau Medical LTD.

Investigators

  • Study Director: Liron Dimnik, Alpha Tau Medical

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

September 22, 2024

First Submitted That Met QC Criteria

September 25, 2024

First Posted (Actual)

September 26, 2024

Study Record Updates

Last Update Posted (Actual)

July 15, 2026

Last Update Submitted That Met QC Criteria

July 14, 2026

Last Verified

September 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CTP-SCC-04

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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