Alpha Radiation Emitters Device for the Treatment of Liver Metastases (DaRT)

NCT05829291 | Recruiting

• 1 other identifier: CTP-LIV-00
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Liver Metastases

Keywords

Alpha radiation; Alpha emitting radiation; Liver Metastases; Brachytherapy

Outcome Measures

Primary Outcomes (2)

• Feasibility - DaRT seed placement

  Assessment of successful placement of the Alpha DaRT Seeds into liver metastases during a 2-stage hepatectomy via imaging

  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.

  Up to 24 months

Secondary Outcomes (2)

• To evaluate the pathological response of liver metastases according to the Modified tumor regression grade 1

  7-9 Weeks post DaRT insertion

• To evaluate the radiological response of liver metastases using the RECIST criteria .

  6-8 weeks post DaRT insertion

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

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".

DaRT Seeds

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Referred for a two staged hepatectomy following a multidisciplinary team discussion, to resect liver metastases of colorectal cancer
• Targetable lesion(s) must be technically amenable for complete coverage (including margins) by the Alpha DaRT Seeds / Target(s) must be reachable for implantation
• Liver lesions are visible and measurable by CT according to RECIST v 1.1
• Age ≥ 18 years old
• ECOG Performance Status Scale ≤ 2
• Subjects' life expectancy is at least 12 weeks
• The following laboratory parameters
• WBC ≥ 3500/µl, granulocyte ≥ 1500/µl
• Hemoglobin \> 85 g/L
• Total bilirubin \< 51.3 umol/L
• Platelet count \>75 X 109 /L or \> 50% Prothrombin activity
• Amylase and lipase \< 1.5 X the upper limit of normal
• AST and ALT ≤ 5 X ULN
• Prothrombin time (PT) international normalized ratio (INR) \< 2.3 or PT \< 6 seconds above control. Patients who are being therapeutically anticoagulated with an agent such as Coumadin or heparin will be allowed to participate provided that no prior evidence of underlying abnormality in these parameters exists
• Subjects are willing and able to sign an informed consent form

You may not qualify if:

• Concurrent cancer that is distinct in primary site or histology from colorectal cancer. Except cervical carcinoma in situ, prostate cancer with good prognosis, treated basal cell carcinoma, superficial bladder tumors (Ta, Tis \& T1). Any cancer curatively treated 3 years prior to entry is permitted.
• Patients undergoing systemic immunosuppressive therapy excepting intermittent, brief use of systemic corticosteroids
• Contraindication to angiography:
• Any bleeding diathesis or coagulopathy that is not correctable by usual therapy or hemostatic agent
• Severe peripheral vascular disease precluding catheterization
• History of severe allergy or intolerance to contrast agents, narcotics, sedatives or atropine that cannot be managed medically
• Known hypersensitivity to any of the components of the treatment.
• Clinically significant cardiovascular disease, e.g. cardiac failure of New York Heart Association classes III-IV, uncontrolled coronary artery disease, cardiomyopathy, uncontrolled arrhythmia, uncontrolled hypertension, or history of myocardial infarction in the last 12 months.
• Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry.
• Brain metastases
• Active clinically serious infections
• Major surgery within 4 weeks of start of the study therapy
• Patients with uncontrolled intercurrent illnesses including, but not limited to an active infection requiring systemic therapy or a known psychiatric or substance abuse disorder(s) that would interfere with cooperation with the requirements of the trial or interfere with the study endpoints.
• Any condition that is unstable or which could jeopardize the safety of the patient and his/her compliance in the study
• High probability of protocol non-compliance (in opinion of investigator)

Sponsors & Collaborators

• Alpha Tau Medical LTD.: lead

Study Sites (1)

e McGill University Health Centre (MUHC)

Montreal, Quebec, H4A 3T2, Canada

RECRUITING

Study Officials

• Peter Metrakos, MD

  McGill University Health Centre/Research Institute of the McGill University Health Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Liron Dimnik

CONTACT

+972237377000; LironD@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: February 27, 2023
• First Posted: April 25, 2023
• Study Start: October 1, 2023
• Primary Completion: February 1, 2025
• Study Completion: February 1, 2026
• Last Updated: May 10, 2024

Record last verified: 2024-05

Locations

CA (1)