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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.
Full description
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.
Enrollment
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Volunteers
Inclusion criteria
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
Subjects are willing and able to sign an informed consent form
Women of childbearing potential (WOCBP) will have evidence of negative pregnancy test within seven days before the Ra-224 implantation
Subjects must agree to use adequate contraception (vasectomy or barrier method of birth control) prior to study entry, for the duration of study participation and for 3 months after discontinuing therapy
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:
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)
Pregnant or breastfeeding women
Volunteers participating in another interventional study in the past 30 days which might conflict with the endpoints of this study or the evaluation of response or toxicity of DaRT
Primary purpose
Allocation
Interventional model
Masking
10 participants in 1 patient group
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Central trial contact
Liron Dimnik
Data sourced from clinicaltrials.gov
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