NCT06202118 A Study of Diffusing Alpha Radiation Therapy for Patients With Breast Carcinoma in Frail or Elderly Patients.
| NCT ID | NCT06202118 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Alpha Tau Medical LTD. |
| Condition | Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 10 participants |
| Start Date | 2024-02-19 |
| Primary Completion | 2026-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 10 participants in total. It began in 2024-02-19 with a primary completion date of 2026-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: * Histologically confirmed invasive breast tumor with no involvement of skin within 12 months. * Tumor size ≤ 4 centimeters in the longest diameter. * Tumor is not deemed as resectable with radical surgery or the patient does not wish to go through surgery * De-novo or recurrent lesions. * Single lesion per quadrant per subject. * Targeted lesion must be technically amenable for complete coverage (including margins) by the DaRT seeds. * Interstitial implant indication validated by multidisciplinary team. * ECOG Performance Status ≤3. * Life expectancy ≥12 months. * Women Age ≥65 or younger if unfit for standard of care. * Willing and have the ability to provide signed Informed Consent. * Blood tests values: * Leucocytes ≥3000mm3, * Absolute neutrophil count ≥1500mm3, * Platelets ≥100,000 mm3, * Total bilirubin ≤ 1.5xULN, * AST, SGOT, SGPT ≤2.5xULN, If Alkaline Phosphatase ≤ 4xULN, then transaminases are normal. * Creatinine ≤ 2.0xULN. * INR or Prothrombin time ≤1.5xULN Exclusion Criteria: * T4 category with skin involvement. * Ductal carcinoma in situ. * Inflammatory breast carcinoma. * Longest tumor diameter \>4 cm. * Patients with prior radiation to the same area within the past 6 months. * Has a known additional malignancy that is progressing or requires active treatment. * Patients undergoing immunosuppressive and/or systemic corticosteroid treatment except for steroid inhalations for treatment of asthma or lung disease * Subjects not willing to sign an informed consent.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06202118 clinical trial?
This trial is open to participants of all sexes, aged 65 Years or older, up to 120 Years, studying Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06202118 currently recruiting?
Yes, NCT06202118 is actively recruiting participants. Contact the research team at LironD@alphatau.com for enrollment information.
Where is the NCT06202118 trial being conducted?
This trial is being conducted at Jerusalem, Israel.
Who is sponsoring the NCT06202118 clinical trial?
NCT06202118 is sponsored by Alpha Tau Medical LTD.. The trial plans to enroll 10 participants.
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