This is a single center study enrolling up to 10 patients. The primary objective is to Evaluate the feasibility and safety of the DaRT for the treatment of Liver Metastases. The secondary objective is to evaluate the pathological response of liver metastases according to the Modified tumor regression grade\[1\] and to evaluate the radiological response of liver metastases using the RECIST criteria.
This study is a Prospective, Open label, one arm, single center study to evaluate the feasibility and safety of Diffusing Alpha Radiation Emitters for the treatment of Liver Metastases . Alpha Tau Medical proposes a unique treatment methodology for patients with liver metastases - Diffusing Alpha-emitters Radiation Therapy (DaRT) - whereby alpha particles are used to destroy solid tumors. The concept is predicated on the use of DaRT radioactive sources for radiotherapy. DaRT is based on a nuclear decay chain originating with thorium-228 (1.91 years half-life). Outside of negligible, non-significant trace amounts, the thorium-228 remains confined to the Alpha Tau Medical manufacturing facility, and is used to generate radium-224, which is coated onto 316LVM stainless steel wires (Alpha DaRT Seeds). The Primary endpoint of the study is : 1) Feasibility assessments of the ability to achieve full volume coverage of liver metastases volume. 2\) Safety of the Alpha DaRT Seeds as therapy for liver metastases , Safety will be assessed and recorded according to CTCAE V5.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
Alpha DaRT Applicators (the Alpha Needle Applicator, the Alpha Flex Applicator, and the Alpha Plant Applicator) and radioactive sources named Alpha DaRT Seeds - Ra-224 coated onto stainless steel tubes inserted into the tumor. Collectively, the Alpha DaRT Applicators and Seeds are referred to as the "Alpha DaRT Device".
e McGill University Health Centre (MUHC)
Montreal, Quebec, Canada
RECRUITINGFeasibility - DaRT seed placement
Assessment of successful placement of the Alpha DaRT Seeds into liver metastases during a 2-stage hepatectomy via imaging
Time frame: From first operation - DaRT insertion up to 24 months
Safety - Adverse events
Assess the frequency and severity of acute adverse events related to DaRT. Adverse events will be assessed and graded according to Common Terminology and Criteria for Adverse Events (CTCAE) version 5.0.
Time frame: Up to 24 months
To evaluate the pathological response of liver metastases according to the Modified tumor regression grade 1
Pathological response to Alpha DaRT Seeds in covered areas after surgery
Time frame: 7-9 Weeks post DaRT insertion
To evaluate the radiological response of liver metastases using the RECIST criteria .
Radiological response to Alpha DaRT seeds implantation after the Alpha DaRT Seeds insertion procedure and prior to the second stage
Time frame: 6-8 weeks post DaRT insertion
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