Actively Recruiting
A Study of Diffusing Alpha Radiation Therapy for Patients With Breast Carcinoma in Frail or Elderly Patients.
Led by Alpha Tau Medical LTD. · Updated on 2025-02-07
10
Participants Needed
1
Research Sites
119 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study of Diffusing Alpha Radiation Therapy for Patients With Breast Carcinoma in Frail or Elderly Patients.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed invasive breast tumor with no skin involvement within 12 months
- Tumor size 4 centimeters or smaller in longest diameter
- Tumor is not suitable for radical surgery or patient declines surgery
- De-novo or recurrent breast lesions
- Single lesion per quadrant per patient
- Lesion technically suitable for complete coverage by DaRT seeds
- Multidisciplinary team validation of interstitial implant indication
- ECOG Performance Status 3 or less
- Life expectancy of at least 12 months
- Women aged 65 or older, or younger if unfit for standard care
- Ability and willingness to provide signed informed consent
- Blood test requirements: leucocytes ≥3000/mm3, absolute neutrophil count ≥1500/mm3, platelets ≥100,000/mm3
- Total bilirubin ≤1.5 times upper limit of normal (ULN)
- AST, SGOT, SGPT ≤2.5 times ULN; if alkaline phosphatase ≤4 times ULN, then transaminases must be normal
- Creatinine ≤2.0 times ULN
- INR or prothrombin time ≤1.5 times ULN
You will not qualify if you...
- Tumor classified as T4 with skin involvement
- Diagnosis of ductal carcinoma in situ
- Inflammatory breast carcinoma
- Tumor larger than 4 centimeters in longest diameter
- Prior radiation to the same area within the past 6 months
- Known additional malignancy that is progressing or requires active treatment
- Current immunosuppressive or systemic corticosteroid treatment, except inhaled steroids for asthma or lung disease
- Unwillingness to sign informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Hadassah Medical Center
Jerusalem, Israel, 9777605
Actively Recruiting
Research Team
L
Liron Dimnik
CONTACT
A
Aviya Hoida
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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