A Study of Diffusing Alpha Radiation Therapy for Patients With Breast Carcinoma in Frail or Elderly Patients.

NCT06202118 | Recruiting

• 1 other identifier: CTP-BRST-07
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer; Recurrent Breast Cancer; Breast Carcinoma

Keywords

Alpha radiation; Breast cancer; Newly Diagnosed Breast Carcinoma; Breast carcinoma

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (1)

• Efficacy - Control evaluation

  3,6,12 and 24 months

Study Arms (1)

DaRT Seeds

EXPERIMENTAL

Intratumoral Diffusing alpha-emitters Radiation Therapy (DaRT) Seeds

Device: Diffusing Alpha Radiation Emitters Therapy (DaRT)

Interventions

Diffusing Alpha Radiation Emitters Therapy (DaRT) DEVICE

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

DaRT Seeds

Eligibility Criteria

• Age: 65 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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,

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alpha Tau Medical LTD.: lead

Study Sites (1)

Hadassah Medical Center

Jerusalem, 9777605, Israel

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Liron Dimnik

CONTACT

+972542688602; LironD@alphatau.com

Aviya Hoida

CONTACT

+972547869466; aviyah@alphatau.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 31, 2023
• First Posted: January 11, 2024
• Study Start: February 19, 2024
• Primary Completion: January 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: February 7, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)