Recruiting
A Study of Diffusing Alpha Radiation Therapy for Patients With Breast Carcinoma in Frail or Elderly Patients.
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.
ClinicalTrials.gov IDNCT06202118
PhaseNA
Enrollment10
SponsorAlpha Tau Medical LTD.
Age65 Years
SexALL
Conditions studied
Breast Cancer, Recurrent Breast Cancer, Breast Carcinoma
About this study
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.
Interventions
- 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
Primary outcomes
- Feasibility -DaRT seed placement (immediately following the insertion procedure)
- Safety- Adverse events (From Day 0)
Eligibility information
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.
Study locations
- Hadassah Medical Center, Jerusalem, 9777605 Israel
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.