RecruitingNot ApplicableNCT03889899

Alpha Radiation Emitters Device (DaRT) for the Treatment of Cutaneous, Mucosal or Superficial Soft Tissue Neoplasia.

A Safety and Effectiveness Study of Intratumoral Diffusing Alpha Radiation Emitters for the Treatment of Malignant Cutaneous, Mucosal or Superficial Soft Tissue Neoplasia

Sponsor

Alpha Tau Medical LTD.

Enrollment

30 participants

Start Date

Oct 21, 2020

Study Type

INTERVENTIONAL

Conditions

Skin Cancer Mucosal Neoplasm of Oral Cavity Soft Tissue Neoplasm

Summary

A unique approach for cancer treatment employing intratumoral diffusing alpha radiation emitter device for superficial cutaneous, mucosal or soft tissue neoplasia

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a treatment device called DaRT (Diffusing Alpha-emitters Radiation Therapy), which delivers targeted radiation from inside a tumor using tiny implanted seeds that emit alpha particles. It is being tested for accessible tumors: skin cancers, oral cavity tumors, and soft tissue sarcomas located near the surface of the body. **You may be eligible if...** - You are over 18 years old - You have a confirmed skin cancer, oral cavity tumor, or superficial soft tissue sarcoma - Your tumor is 7 cm or smaller at its widest point - Your tumor is measurable and you are in reasonable health (ECOG 0–1) with more than 6 months life expectancy - Your blood counts and kidney function meet required levels **You may NOT be eligible if...** - Your tumor is a keratoacanthoma type - You are pregnant or breastfeeding - Your platelet count, kidney function, or clotting is outside safe limits - You have conditions preventing safe placement of the radiation seeds Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICERadiation: Diffusing Alpha Radiation Emitters Therapy (DaRT)

An intratumoral insertion of a seed(s), loaded with Radium-224, securely fixed in the seeds. The seeds release by recoil into the tumor short-lived alpha-emitting atoms.