RecruitingNot ApplicableNCT04534127

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

56 participants

Start Date

Dec 22, 2020

Study Type

INTERVENTIONAL

Conditions

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 new radiation device called DaRT (Diffusing Alpha-emitters Radiation Therapy) — small seeds inserted into a tumor that release targeted alpha radiation — for patients with skin, mouth, or soft tissue tumors who cannot receive or have failed standard treatments. **You may be eligible if...** - You are 18 or older with confirmed malignant skin, oral, or superficial soft tissue cancer - Your tumor is 7 cm or smaller - The tumor can be fully reached and covered by the DaRT seeds - You have either already tried standard treatment (surgery, radiation, or chemotherapy) and it failed, OR you are not a candidate for standard treatment, OR you have declined standard treatment - Your general health is reasonable (ECOG performance status 0–2) **You may NOT be eligible if...** - Your tumor is larger than 7 cm - Your tumor cannot be safely accessed for seed placement - You have rapidly spreading disease or poor overall health 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.


Locations(1)

Sharett institute, Hadassah Medical Center - Ein-Kerem

Jerusalem, Israel

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NCT04534127


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