Who is eligible for clinical trial NCT05829291?

Participants must meet the protocol's inclusion criteria for Liver Metastases. The stated age range is 18 Years. Confirm all requirements with the study coordinator.

Does clinical trial NCT05829291 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

Alpha Radiation Emitters Device (DaRT) for the Treatment of Liver Metastases (NCT05829291)

A Feasibility and Safety Study of Intratumoral Diffusing Alpha Radiation Emitters for the Treatment of Liver Metastases

🟢 Recruiting Observational / Diagnostic ⚙️ Medical Device Protocol Sponsor: Alpha Tau Medical LTD.

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (17 items) and avoid the listed exclusions (18 items).

Location: e McGill University Health Centre (MUHC) — Montreal, Quebec

Age range: 18 Years

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Usually NOT eligible if any of the following apply:

Exclusion Criteria:
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

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (1 Sites)

e McGill University Health Centre (MUHC) — Montreal, Quebec

📞 Contact the Study Coordinator

Phone: +972237377000

Email: LironD@alphatau.com

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

💡 How to Participate

Check the checklist above to see if you may qualify.
Contact the study coordinator using the phone/email above.
Ask about the visit schedule, what is covered at no cost, and any travel support.
Confirm with your own doctor before making a decision.

🏛️ View Official NIH Record ↗