Clinical Research Directory
Browse clinical research sites, groups, and studies.
Alpha Radiation Emitters Device (DaRT) for Target Treatments of Malignant Tumors
Sponsor: Alpha Tau Medical LTD.
Summary
This study is a Compassionate clinical study for the treatment of Malignant Tumors. The primary endpoint of the study is to assess the frequency, severity and causality of acute adverse events related to the DaRT treatment. Adverse events will be assessed and graded according to Common Terminology and Criteria for Adverse Events (CTCAE) version 5.0. The secondary endpoint is to assess the tumor response to DaRT treatment assessed using the Response Evaluation Criteria in Solid Tumors (RECIST) (Version 1.1) 3 months after DaRT seed insertion.
Official title: A Prospective, Open Label, One Arm Study for a Compassionate Use of Diffusing Alpha Radiation Therapy
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
100
Start Date
2023-03-22
Completion Date
2027-04
Last Updated
2026-04-06
Healthy Volunteers
No
Conditions
Interventions
Experimental: DaRT seeds
DaRT source will be inserted using preplanned radiotherapy parameters and reassessed by volumetric imaging 2-3 weeks after placement and then removed. The study objectives are to collect data on the general safety and efficacy of DaRT among patients who do not fit the entry criteria of existing investigational trials.
Locations (1)
Hadassah Ein Kerem
Jerusalem, Israel