A Study of Diffusing Alpha Radiation Therapy for Patients With Breast Carcinoma in Frail or Elderly Patients.
- Conditions
- Recurrent Breast CancerBreast CancerBreast Carcinoma
- Interventions
- Device: Diffusing Alpha Radiation Emitters Therapy (DaRT)
- Registration Number
- NCT06202118
- Lead Sponsor
- Alpha Tau Medical LTD.
- 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 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
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 10
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Histologically confirmed invasive breast tumor with no involvement of skin within 12 months.
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Tumor size ≤ 4 centimeters in the longest diameter.
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Tumor is not deemed as resectable with radical surgery or the patient does not wish to go through surgery
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De-novo or recurrent lesions.
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Single lesion per quadrant per subject.
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Targeted lesion must be technically amenable for complete coverage (including margins) by the DaRT seeds.
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Interstitial implant indication validated by multidisciplinary team.
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ECOG Performance Status ≤3.
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Life expectancy ≥12 months.
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Women Age ≥65 or younger if unfit for standard of care.
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Willing and have the ability to provide signed Informed Consent.
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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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description DaRT Seeds Diffusing Alpha Radiation Emitters Therapy (DaRT) Intratumoral Diffusing alpha-emitters Radiation Therapy (DaRT) Seeds
- Primary Outcome Measures
Name Time Method Feasibility -DaRT seed placement immediately following the insertion procedure Feasibility will be determined according to the Rate of successful placement of DaRT seeds via imaging
Safety- Adverse events From Day 0 Safety will be determined according to the overall incidence of device related SAE'sgraded according to CTCAE v5.0 criteria
- Secondary Outcome Measures
Name Time Method Efficacy - Control evaluation 3,6,12 and 24 months To evaluate efficacy, as determined by local control evaluation according to RECIST v1.1
Trial Locations
- Locations (1)
Hadassah Medical Center
🇮🇱Jerusalem, Israel