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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06202118
Other study ID # CTP-BRST-07
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date February 19, 2024
Est. completion date June 2026

Study information

Verified date December 2023
Source Alpha Tau Medical LTD.
Contact Liron Dimnik
Phone +972542688602
Email LironD@alphatau.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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 information / eligibility

Status Recruiting
Enrollment 10
Est. completion date June 2026
Est. primary completion date January 2026
Accepts healthy volunteers No
Gender All
Age group 65 Years to 120 Years
Eligibility 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 Design


Intervention

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

Locations

Country Name City State
Israel Hadassah Medical Center Jerusalem

Sponsors (1)

Lead Sponsor Collaborator
Alpha Tau Medical LTD.

Country where clinical trial is conducted

Israel, 

Outcome

Type Measure Description Time frame Safety issue
Primary Feasibility -DaRT seed placement Feasibility will be determined according to the Rate of successful placement of DaRT seeds via imaging immediately following the insertion procedure
Primary Safety- Adverse events Safety will be determined according to the overall incidence of device related SAE'sgraded according to CTCAE v5.0 criteria From Day 0
Secondary Efficacy - Control evaluation To evaluate efficacy, as determined by local control evaluation according to RECIST v1.1 3,6,12 and 24 months
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