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Clinical Study Protocol for Cutaneous SCC for Immunocompromised Patients

NCT06615635 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2025-12-02

No results posted yet for this study

Summary

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Alpha Tau Medical LTD.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-31
Primary Completion
2025-12-31
Completion
2026-12-31
FDA Device
Yes

Countries

  • United States
  • Israel

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06615635 on ClinicalTrials.gov