Liver MetastasesNCT05829291
Alpha Radiation Emitters Device (DaRT) for the Treatment of Liver Metastases
A study testing Diffusing Alpha Radiation Emitters Therapy (DaRT) in people with Liver Metastases, run by Alpha Tau Medical LTD. at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Metastases
- What is being tested?
- Diffusing Alpha Radiation Emitters Therapy (DaRT)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteCanada
- Study dates
- 1 Oct 2023to Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
- 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
Who cannot join
- 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
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- 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
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
e McGill University Health Centre (MUHC)
Montreal, Quebec, H4A 3T2
Peter Metrakos, MD
Anthoula Lazaris, anthoula.lazaris@mail.mcgill.ca
About this study
Official title: A Feasibility and Safety Study of Intratumoral Diffusing Alpha Radiation Emitters for the Treatment of Liver Metastases
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.
Read the detailed 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.
- Safety of the Alpha DaRT Seeds as therapy for liver metastases , Safety will be assessed and recorded according to CTCAE V5.
- Conditions
- Liver Metastases
- Being tested
- Diffusing Alpha Radiation Emitters Therapy (DaRT)
- Keywords
- Alpha radiation, Alpha emitting radiation, Liver Metastases, Brachytherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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".
| Study group | Role | What they receive |
|---|---|---|
| DaRT Seeds | Experimental | Intratumoral Diffusing alpha-emitters Radiation Therapy (DaRT) Seeds Receives: Device: Diffusing Alpha Radiation Emitters Therapy (DaRT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility - DaRT seed placement
Assessment of successful placement of the Alpha DaRT Seeds into liver metastases during a 2-stage hepatectomy via imaging
Measured: 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.
Measured: Up to 24 months
Secondary outcomes (2)
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
Measured: 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
Measured: 6-8 weeks post DaRT insertion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2023
- Study start1 Oct 2023
- Primary completionFeb 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver MetastasesStudies of the same condition, open and under way.
- More trials run by Alpha Tau Medical LTD.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alpha Tau Medical LTD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Peter Metrakos, MD, Principal investigator, McGill University Health Centre/Research Institute of the McGill University Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05829291
- Sponsor's protocol ID
- CTP-LIV-00
- Status last verified
- May 2026
- First submitted
- 27 Feb 2023
- Last updated
- 16 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility and Safety Study of Intratumoral Diffusing Alpha Radiation Emitters for the Treatment of Liver Metastases
- ClinicalTrials.gov ID
- NCT05829291
- Acronym / sponsor ID
- CTP-LIV-00
- Conditions
- Liver Metastases
- Keywords
- Alpha radiation, Alpha emitting radiation, Liver Metastases, Brachytherapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Alpha Tau Medical LTD.Industry (pharma, biotech, devices)
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 25 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
- Safety of the Alpha DaRT Seeds as therapy for liver metastases , Safety will be assessed and recorded according to CTCAE V5.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DaRT Seeds | Experimental | Device: Diffusing Alpha Radiation Emitters Therapy (DaRT)Intratumoral Diffusing alpha-emitters Radiation Therapy (DaRT) Seeds |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- 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
Key exclusion criteria (18 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diffusing Alpha Radiation Emitters Therapy (DaRT)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". | Device | DaRT Seeds |
Primary outcome
Feasibility - DaRT seed placement
Time frame: From first operation - DaRT insertion up to 24 months
Assessment of successful placement of the Alpha DaRT Seeds into liver metastases during a 2-stage hepatectomy via imaging
Safety - Adverse events
Time frame: Up to 24 months
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.
2 secondary outcomes
To evaluate the pathological response of liver metastases according to the Modified tumor regression grade 1
Time frame: 7-9 Weeks post DaRT insertion
To evaluate the radiological response of liver metastases using the RECIST criteria .
Time frame: 6-8 weeks post DaRT insertion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Peter Metrakos, MD principal investigator
McGill University Health Centre/Research Institute of the McGill University Health Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diffusing Alpha Radiation Emitters Therapy (DaRT) in people with Liver Metastases, run by Alpha Tau Medical LTD. at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Liron Dimnik (+972237377000, LironD@alphatau.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility - DaRT seed placement (time frame: From first operation - DaRT insertion up to 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2026.