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New radiation therapy shows promise for liver metastases in early trial

NCT ID NCT05829291

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

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

About 10 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2023

Expected to finish

Jul 2027

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • e McGill University Health Centre (MUHC)

    RECRUITING

    Montreal, Quebec, H4A 3T2, Canada

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