Alpha Radiation Emitters Device (DaRT) for the Treatment of Liver Metastases
ConditionLiver Metastases
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAlpha Tau Medical LTD.
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Any bleeding diathesis or coagulopathy that is not correctable by usual therapy or hemostatic agent
Severe peripheral vascular disease precluding catheterization
Trial design
Treatments tested in this trial
- Diffusing Alpha Radiation Emitters Therapy (DaRT)
Treatment groups
10 Participants
are divided into 1 treatment groupLocations
1e McGill University Health Centre (MUHC)H4A 3T2, MontrealQuebec, Canada
Sponsors and collaborators
Alpha Tau Medical LTD.
Lead sponsor
Source ClinicalTrials.gov