New radiation therapy shows promise for liver metastases in early trial
NCT ID NCT05829291
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study is testing a new type of radiation therapy called DaRT for people with liver tumors that have spread from colorectal cancer. The treatment involves placing tiny radioactive seeds directly into the tumors during surgery. The goal is to see if this approach is safe and feasible, and to measure how well it shrinks or destroys the tumors. Up to 10 participants will be enrolled.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 10 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2023
- Expected to finish
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Jul 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Referred for a two staged hepatectomy following a multidisciplinary team discussion, to resect liver metastases of colorectal cancer 2. Targetable lesion(s) must be technically amenable for complete coverage (including margins) by the Alpha DaRT Seeds / Target(s) must be reachable for implantation 3. Liver lesions are visible and measurable by CT according to RECIST v 1.1 4. Age ≥ 18 years old 5. ECOG Performance Status Scale ≤ 2 6. Subjects' life expectancy is at least 12 weeks 7. 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 8. Subjects are willing and able to sign an informed consent form 9. Women of childbearing potential (WOCBP) will have evidence of negative pregnancy test within seven days before the Ra-224 implantation 10. 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: 1. 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. 2. Patients undergoing systemic immunosuppressive therapy excepting intermittent, brief use of systemic corticosteroids 3. 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 4. Known hypersensitivity to any of the components of the treatment. 5. 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. 6. Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry. 7. Brain metastases 8. Active clinically serious infections 9. Major surgery within 4 weeks of start of the study therapy 10. 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. 11. Any condition that is unstable or which could jeopardize the safety of the patient and his/her compliance in the study 12. High probability of protocol non-compliance (in opinion of investigator) 13. Pregnant or breastfeeding women 14. 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 \-
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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e McGill University Health Centre (MUHC)
RECRUITINGMontreal, Quebec, H4A 3T2, Canada
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can a Pressure-Sensitive catheter sharpen Radiation's aim at liver tumors?
- Can removing liver tumors alongside the whipple procedure extend life in stage IV pancreatic cancer?
- Mapping tumors in 3D: could imaging reveal hidden growth patterns?
- A new test could reveal how radiation affects the liver
- A new clue in the fight against colorectal cancer recurrence?