Actively Recruiting
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
Led by Alpha Tau Medical LTD. · Updated on 2025-02-07
10
Participants Needed
1
Research Sites
21 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a unique cancer treatment using an intratumoral diffusing alpha radiation emitter device called DaRT for patients with newly diagnosed or recurrent breast carcinoma who are frail or elderly. This prospective, open-label, single-arm, multi-center interventional study aims to assess the feasibility and safety of DaRT seeds in this patient group, including breast cancer subtypes such as HR+/HER-2-, HR+/HER-2+, HR-/HER-2-, and HR-/HER-2+. Participants will undergo a screening period followed by the DaRT seeds insertion procedure directly into the tumor. After insertion, there is an acute follow-up phase lasting 4 to 8 weeks, then a long-term follow-up phase extending up to 24 months. The total study duration is 24 months from the time of the DaRT insertion. A total of 10 participants will be enrolled, and all will receive the intratumoral DaRT seeds treatment. Throughout the study, participants will be monitored regularly to evaluate the placement feasibility of the DaRT seeds immediately after insertion and to track any adverse events from day 0. Researchers will assess disease control at 3, 6, 12, and 24 months post-treatment. Blood tests and clinical evaluations will be conducted as part of screening and follow-up. The study does not include a control group or masking.
CONDITIONS
Brief 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 less in the longest diameter
- Tumor not suitable for radical surgery or patient declines surgery
- New or recurrent single lesion per quadrant
- Lesion technically amenable for complete coverage by DaRT seeds
- Interstitial implant indication validated by multidisciplinary team
- 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 values within specified limits for leucocytes, neutrophils, platelets, bilirubin, liver enzymes, creatinine, and coagulation
You will not qualify if you...
- T4 tumor category with skin involvement
- Ductal carcinoma in situ
- Inflammatory breast carcinoma
- Tumor size greater than 4 centimeters
- Prior radiation to the same area within 6 months
- Known additional progressing malignancy requiring active treatment
- 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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Day 0
Participants undergo intratumoral insertion of Diffusing Alpha Radiation Emitters Therapy (DaRT) seeds.
1 procedure visit (in-person)
Duration - 4 to 8 weeks
Participants are monitored closely during the acute follow-up phase to assess feasibility and safety of the DaRT seed placement.
Weekly visits for up to 8 weeks
Duration - 24 months
Participants are monitored for efficacy and safety over a long-term follow-up period of up to 24 months after the DaRT insertion.
Visits at 3, 6, 12, and 24 months
Trial Site Locations
Total: 1 location
1
Hadassah Medical Center
Jerusalem, Israel, 9777605
Actively Recruiting
Research Team
L
Liron Dimnik
A
Aviya Hoida
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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