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

Conditions

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

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• DaRT seeds — DEVICE
  Diffusing Alpha emitters Radiation (DaRT) treatment to be delivered through radioactive sources inserted into malignant cutaneous squamous cell carcinoma of Immunocompromised Patients

Study Details

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 Dates

First listed

Sep 26, 2024

Start date

Jan 1, 2026

Status verified

Sep 2025

Primary completion

Dec 31, 2026

Completion

Dec 31, 2026

Study Design

Enrollment

28 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• 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

Primary Outcome Measure

objective response rate [ Time Frame: From Day 14 until 52 weeks ]

Central Contacts

• Liron Dimnik
  +972-2-3737-210
  [email protected]
• Aviya Hoida
  +972-2-3737-210
  [email protected]

Locations (10)

Find similar trials in Gilbert, AZ

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