An interventional study of Diffusing Alpha Radiation Emitters Therapy (DaRT) in Breast Cancer, Recurrent Breast Cancer and Breast Carcinoma, sponsored by Alpha Tau Medical LTD.. Recruiting at 1 site in Israel. Open to participants aged 65 Years to 120 Years. Per ClinicalTrials.gov, last updated 2025-02-07.
Sponsored by Alpha Tau Medical LTD. · Not applicable, Interventional, and Treatment
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.
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 Recurrent Breast Carcinoma in frail or elderly patients.
The study will be comprised of a screening period, DaRT insertion visit, acute follow-up phase of 4- 8 weeks and a long-term follow up phase of 24 months. The total duration of the study will be 24 months from the DaRT insertion procedure.
A total of 10 subjects will be enrolled from all breast cancer subtypes (HR+/HER-2-, HR+/HER-2+, HR-/HER-2-, and HR-/HER-2-.). No formal interim analysis is planned for this study.
Eligible patients who meet inclusion/exclusion criteria (as assessed during the screening period) will be invited to the site for the procedure of DaRT seeds insertion. The patients will be monitored for a period of 24 months post insertion
6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.
This study's planned enrollment of 10 is below the median of 45 across 5,170 interventional studies indexed under Carcinoma.
Browse Carcinoma studies →Alpha Tau Medical LTD. is the lead sponsor of 28 studies on the registry; 18 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Blood tests values:
Exclusion Criteria:
Intratumoral Diffusing alpha-emitters Radiation Therapy (DaRT) Seeds
Device: Diffusing 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
Feasibility -DaRT seed placement
Feasibility will be determined according to the Rate of successful placement of DaRT seeds via imaging
Time frame: immediately following the insertion procedure
Safety- Adverse events
Safety will be determined according to the overall incidence of device related SAE'sgraded according to CTCAE v5.0 criteria
Time frame: From Day 0
Efficacy - Control evaluation
To evaluate efficacy, as determined by local control evaluation according to RECIST v1.1
Time frame: 3,6,12 and 24 months
Plan to share: No
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Alpha Tau Medical LTD.