RecruitingNot ApplicableNCT04068155

Alpha Radiation Emitters Device for the Treatment of of Malignant Cutaneous Tumors

A Safety and Effectiveness Study of Intratumoral Diffusing Alpha Radiation Emitters for the Treatment of Malignant Cutaneous Tumors


Sponsor

Alpha Tau Medical LTD.

Enrollment

80 participants

Start Date

Apr 1, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

A unique approach for cancer treatment employing intratumoral diffusing alpha radiation emitter device for Malignant Cutaneous Tumors


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new type of internal radiation treatment using radioactive seeds (called Alpha DaRT) for skin cancer tumors. The seeds are implanted directly into the tumor and release radiation to destroy cancer cells from the inside out. **You may be eligible if...** - You are over 18 years old - You have been diagnosed with a skin cancer (squamous cell carcinoma, basal cell carcinoma, lentigo maligna melanoma, or carcinosarcoma) — either newly diagnosed or locally recurrent - Your tumor is 7 centimeters or smaller in its longest dimension - Your tumor is located on the skin (face, scalp, limbs, torso), lips, or eyelids - You are in reasonable health (able to carry out daily activities) - You have adequate blood clotting function **You may NOT be eligible if...** - Your tumor cannot be fully covered by the radioactive seeds - Your tumor is larger than 7 centimeters - You have poor overall health or a life expectancy of less than 6 months - Your blood counts or clotting factors are too low 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

DEVICEDaRT- Diffusing Alpha-emitters Radiation Therapy

Seed(s) loaded with Radium-224 for local intratumoral irradiation with the destructive power of alpha particles


Locations(2)

CHU Grenoble Alpes

Grenoble, France

Centre Léon Bérard

Lyon, France

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NCT04068155


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