What is the DaRT device studying for cutaneous squamous cell carcinoma in immunocompromised patients?

This study is evaluating the safety and effectiveness of the DaRT device, which delivers alpha radiation directly into skin cancer tumors in immunocompromised patients. Researchers want to see how well it controls the tumor and improves survival over 12 months. The study is sponsored by Alpha Tau Medical LTD.

Who may be eligible for this cutaneous squamous cell carcinoma clinical trial?

Adults aged 18 or older with confirmed cutaneous squamous cell carcinoma and immunocompromised status may be eligible. Participants must have a single tumor up to 7 cm that can be treated with the device and be able to undergo multiple CT scans. Please review eligibility criteria for more details.

Is there any cost to participate in this cutaneous squamous cell carcinoma clinical trial?

Study-related care, including the study device and all trial visits, is provided at no cost. However, personal travel expenses and other costs related to participation may vary and are not guaranteed to be covered.

Actively Recruiting

Phase Not Applicable

Age: 18Years +

All Genders

ID06615635

Study to Evaluate the Safety and Effectiveness of Intratumoral Alpha DaRT-224 Treatment for Immunocompromised Patients With Cutaneous Squamous Cell Carcinoma

Led by Alpha Tau Medical LTD. · Updated on 2026-07-15

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

This trial evaluates the safety and effectiveness of intratumoral Alpha DaRT-224, a device delivering diffusing alpha-emitter radiation, in treating immunocompromised patients with cutaneous squamous cell carcinoma SCC. The study aims to measure the objective response rate ORR using RECIST v1.1 criteria and track progression-free survival PFS, overall survival OS, and local tumor control up to 12 months after treatment. It is a multicenter, single-arm, open-label clinical study involving up to 28 participants. Participants will receive DaRT seeds, which are encapsulated Radium-224 radioactive sources inserted directly into the SCC tumor. These sources emit short-lived alpha particles locally in the tumor microenvironment. The seeds remain implanted for 14 to 21 days before removal. The treatment targets tumors up to 7 cm in size with single lesions that can be fully covered by the radiation sources. The study does not include a comparison group. During the study, participants will undergo multiple CT scans and blood tests to monitor tumor response and safety. Researchers will assess the best overall tumor response starting from the time of DaRT seed removal. Adverse events related to the device will be classified and recorded according to established criteria. Patients must provide informed consent and will be followed for up to 12 months after seed insertion to evaluate survival and tumor control outcomes.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Patients with histologically confirmed cutaneous squamous cell carcinoma
Histopathological confirmation within 6 months of enrollment with no tumor treatment between biopsy and enrollment
Immunocompromised due to primary or secondary immunodeficiencies
Measurable disease according to RECIST v1.1
Able and willing to undergo multiple CT scans
Tumor size 7 cm or less at longest diameter
Single lesion per subject
Lesion technically amenable for complete coverage by DaRT seeds
Interstitial implant indication validated by multidisciplinary team
ECOG performance status 0 to 2
Life expectancy of at least 12 months
Age 18 years or older
Able and willing to provide signed informed consent
Patients with reproductive potential must use effective birth control for 1 year after DaRT insertion
Women with childbearing potential must have negative pregnancy test during screening and prior to DaRT insertion
Adequate blood test values for platelets, bilirubin, liver enzymes, alkaline phosphatase, creatinine clearance, and coagulation tests

You will not qualify if you...

Distant or nodal metastatic disease (N+ or M1)
T4 disease
Extensive perineural invasion
Previously untreated cutaneous SCC
Mucosal SCC
Inability to fully cover entire tumor volume with DaRT seeds
Inability to place DaRT seeds due to bone, vessels, or vital organs
Inability or unwillingness to undergo multiple CT scans
Receipt of chemotherapy, biological therapy, immunotherapy, investigational agents, radiation therapy within 4 weeks prior to enrollment
Live vaccines within 30 days before first treatment and during trial
Tumor larger than 7 cm
Tumor with keratoacanthoma histology
Known hypersensitivity to treatment components
Clinically significant cardiovascular disease
Medical or psychiatric illness compromising treatment tolerance or protocol adherence
Serious medical comorbidities affecting compliance or safety assessment
High probability of protocol non-compliance
Participation in conflicting interventional studies within past 30 days
Known progressing additional malignancy requiring active treatment (exceptions apply)
Refusal or inability to use adequate contraception before and 1 year after DaRT insertion
Breastfeeding or pregnant women
Tattoos, scars, body jewelry, or marks that cannot be hidden for digital photos

Research Team

Liron Dimnik

Aviya Hoida

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