RecruitingNot ApplicableNCT06202118

A Study of Diffusing Alpha Radiation Therapy for Patients With Breast Carcinoma in Frail or Elderly Patients.

A Pilot Feasibility and Safety Trial of Intratumoral Diffusing Alpha-emitter Radiation Therapy (DaRT) for the Treatment of Newly Diagnosed or Recurrent Breast Carcinoma in Frail or Elderly Patients.


Sponsor

Alpha Tau Medical LTD.

Enrollment

10 participants

Start Date

Feb 19, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

A unique approach for cancer treatment employing intratumoral diffusing alpha radiation emitter device for the treatment of newly diagnosed or Recurrent Breast Carcinoma in frail or elderly patients.


Eligibility

Min Age: 65 YearsMax Age: 120 Years

Plain Language Summary

Simplified for easier understanding

This trial tests a radiation treatment called Alpha DaRT (diffusing alpha radiation therapy), where small radioactive seeds are placed directly inside a breast tumor, for elderly or frail patients who cannot have standard surgery. **You may be eligible if...** - You have an invasive breast tumor confirmed by biopsy, no larger than 4 centimeters - You are a woman aged 65 or older, or younger if you are not fit for standard surgery - You are not a candidate for standard surgery or prefer not to have it - You have only one tumor in the treatment area - Your general health is reasonable (ECOG score 3 or below) - Your blood counts and organ function are adequate **You may NOT be eligible if...** - Your tumor has grown into the skin - You have inflammatory breast cancer - You have had radiation to the same breast area in the last 6 months - You are taking immunosuppressants or high-dose steroids (other than inhalers) - You are pregnant or breastfeeding 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

DEVICEDiffusing Alpha Radiation Emitters Therapy (DaRT)

An intratumoral insertion of radioactive sources \[Ra-224 containing stainless-steel 316LVM tubes- (Alpha DaRT seeds)\]. The seeds release by recoil into the tumor short-lived alpha-emitting atoms


Locations(1)

Hadassah Medical Center

Jerusalem, Israel

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NCT06202118


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