NCT03970967

Alpha Radiation Emitters Device for the Treatment of Newly Diagnosed Breast Carcinoma Patients With Distant Metastases

A Safety and Effectiveness Study of Intratumoral Diffusing Alpha Radiation Emitters for the Treatment of Newly Diagnosed Breast Carcinoma Patients With Distant Metastases

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: Alpha Tau Medical LTD. · Industry
• Sex: All
• Age: 45 Years
• Healthy volunteers: Not accepted

Summary

A unique approach for cancer treatment employing intratumoral diffusing alpha radiation emitter device for newly Diagnosed Breast Carcinoma patients with distant metastases

Detailed description

This will be a prospective, open label, single arm, controlled study, assessing the safety and efficacy of diffusing alpha emitters radiation therapy (DaRT) delivered through radioactive sources \[Ra-224 containing stainless-steel 316LVM tubes- (Alpha DaRT seeds)\] inserted into malignant breast lesions. This approach combines the advantages of local intratumoral irradiation of the tumor, as used in conventional brachytherapy, with the power of the alpha radiation emitting atoms, that will be introduced in quantities considerably lower than radiation therapy already used in patients. Histopathological confirmed invasive breast tumors with no involvement of skin will be treated using DaRT seeds. The primary effectiveness endpoint of the study is the tumor response to DaRT treatment assessed using the Response Evaluation Criteria in Solid Tumors (RECIST) (Version 1.1) 9-11 weeks after DaRT seed insertion. Safety will be assessed by the cumulative frequency, severity and causality of acute adverse events related to the DaRT treatment of adverse events (AEs) observed including the follow-up period.

Conditions

• Breast Carcinoma
• Metastatic Breast Cancer
• Invasive Breast Cancer
• Distant Metastases.Pathology

Interventions

Type	Name	Description
DEVICE	Device: Radiation: 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.

Timeline

• Start date: 2019-08-28
• Primary completion: 2023-11-30
• Completion: 2023-11-30
• First posted: 2019-06-03
• Last updated: 2024-01-18

Locations

1 site across 1 country: Russia