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DaRT for Cutaneous Squamous Cell Carcinoma in Immunocompromised Patients

This study is testing a treatment called Diffusing Alpha-emitters Radiation Therapy (DaRT) for people who have cutaneous squamous cell carcinoma (a type of skin cancer) and are immunocompromised (have a weakened immune system). The DaRT treatment involves placing small radioactive sources, called DaRT seeds, directly into the tumor. These seeds release alpha-emitting atoms to target the cancer cells. Researchers want to see how many patients' tumors shrink or disappear after this treatment. Up to 28 participants will be enrolled. To join, you must be at least 18 years old, have a confirmed diagnosis of cutaneous squamous cell carcinoma within the last 6 months, be immunocompromised, and have measurable disease. The study is currently unclear on its recruitment status.

Study design
This is a multi-center study involving up to 28 participants. It is an open-label study, meaning both you and your doctors will know what treatment you are receiving.
What's involved
You would undergo multiple CT scans to monitor the tumor. The DaRT sources will be inserted into your tumor and removed after 14-21 days.
Compensation
Not stated in the trial record.
Follow-up
Your response to treatment will be measured from Day 14 until 52 weeks after the DaRT sources are removed. Progression-free survival, overall survival, and local control will be assessed for up to 12 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06615635

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

Recruiting
NAAges 18+InterventionalTreatment
Alpha Tau Medical LTD.
~28 participants
Updated 2026-07-15 on ClinicalTrials.gov
What's tested:DaRT seeds

At a glance

Recruiting sites
6 of 11 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
objective response rate
Measured over From Day 14 until 52 weeks

Conditions

Squamous Cell Carcinoma
Alpha Radiation
Immunocompromised
Carcinoma, Squamous
Skin Cancer
Brachytherapy

Explore related trials

Squamous Cell Carcinoma

Where it's being run

11 sites across 6 states
Florida4
Arizona3
Georgia1
Minnesota1
New York1
Israel1

Study leadership

  • Liron Dimnik · STUDY_DIRECTOR · Alpha Tau Medical

Who to contact

Liron Dimnik
[email protected]
+972-2-3737-210
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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.
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

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

What this trial measures

  • objective response rateFrom 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).