Status:
RECRUITING
A Study of Diffusing Alpha Radiation Therapy for Patients With Breast Carcinoma in Frail or Elderly Patients.
Lead Sponsor:
Alpha Tau Medical LTD.
Conditions:
Breast Cancer
Recurrent Breast Cancer
Eligibility:
All Genders
65-120 years
Phase:
NA
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.
Detailed Description
This is a Prospective Open label Single arm multi-center interventional study. The study is designed to evaluate the Feasibility and Safety of DaRT seeds for the treatment of newly diagnosed or Recurr...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 19 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2026
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT06202118
Start Date
February 19 2024
End Date
June 1 2026
Last Update
February 7 2025
Active Locations (1)
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1
Hadassah Medical Center
Jerusalem, Israel, 9777605