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MRI-Guided radiation shows promise for brain tumors in new trial

NCT ID NCT07586657

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 phase 3 trial tests a new type of radiotherapy that uses daily MRI scans to precisely target brain metastases from lung cancer. The approach, called MR-guided adaptive radiotherapy, adjusts the radiation dose based on real-time tumor changes. Researchers hope it will improve local control and reduce brain damage compared to standard methods. The study enrolls 200 patients with large or complex brain metastases who have not had prior brain radiation.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
adaptive radiotherapy (MR-guided)
What this could lead to
If successful, this could establish a new standard for treating large or complex brain metastases, offering better tumor control and fewer side effects than current methods.
What could go wrong
This is a single-arm phase 3 study without a control group, so results may be less definitive. The treatment is time-consuming (40-60 minutes per session) and may not be suitable for all patients.

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

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 200 people

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

Expected to start

Apr 2026

An estimate. Start dates often move.

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

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. Pathologically diagnosed non-small cell lung cancer or small cell lung cancer; 2. Brain metastases diagnosed by contrast-enhanced MRI; 3. KPS ≥ 60, or KPS ≥ 40 if caused solely by intracranial tumors; 4. Brain metastases with a diameter ≥ 2 cm or volume ≥ 6 cm³, with 1-3 lesions; 5. No prior brain radiotherapy; 6. Able to undergo MRI examination; 7. Good compliance and ability to lie flat for more than 45 minutes; 8. No major organ dysfunction, etc.; 9. Signed informed consent and agreement to receive post-treatment follow-up; 10. All patients must be willing to provide tumor tissue samples before randomization; 11. At least one measurable tumor lesion according to RECIST v1.1 or iRECIST criteria. Exclusion Criteria: 1. Other serious illnesses; 2. Presence of implants in the patient's body, such as cardiac pacemakers, prostheses, or surgical stents, particularly cerebrovascular stents; 3. Presence of shrapnel, bullets, or other foreign objects anywhere in the body; 4. Severe back pain when lying supine; 5. Severe claustrophobia; 6. Inability to complete treatment or estimated survival \< 3 months; 7. Currently participating in other clinical trials for the treatment of brain metastases; 8. Prior history of intracranial radiotherapy; 9. Unstable angina, myocardial infarction, coronary artery bypass grafting, congestive heart failure, cerebrovascular accident (including transient ischemic attack, pulmonary embolism) within 3 months prior to enrollment; 10. Persistent arrhythmia (CTCAE grade ≥ 2), atrial fibrillation of any degree, prolonged QTc interval ( \> 450 ms in males, \> 470 ms in females); 11. Refractory hypertension (blood pressure still \> 150/100 mm Hg despite optimal medical therapy); 12. Known history of human immunodeficiency virus (HIV) infection; 13. Pregnant or breastfeeding women; 14. Receipt of a live vaccine within 30 days prior to the first dose of study drug. Live vaccines include, but are not limited to: measles, mumps, rubella, varicella/zoster (chickenpox), yellow fever, rabies, bacillus Calmette-Guérin (BCG), and typhoid vaccines. Seasonal influenza vaccines for injection are typically inactivated virus vaccines and are permitted; however, intranasal influenza vaccines (e.g., FluMist®) are live attenuated vaccines and are not permitted; 15. Active autoimmune disease requiring systemic treatment (i.e., immunomodulatory drugs, corticosteroids, or immunosuppressive drugs) within the past 2 years (autoimmune diseases include, for example: autoimmune hepatitis, interstitial pneumonia, uveitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid syndrome-associated vascular thrombosis, Wegener's granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, glomerulonephritis, hyperthyroidism or hypothyroidism, asthma requiring bronchodilators, etc., i.e., immunomodulatory drugs, corticosteroids, or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered systemic treatment and is permitted; 16. Concomitant medical contraindications to receiving any contrast-enhanced imaging examination (CT or MRI); 17. Severe hypersensitivity (grade ≥ 3) to the study intervention and/or any of its excipients; 18. Uncontrolled metabolic disorders or other non-malignant organ or systemic diseases, or secondary responses to cancer that may lead to increased medical risk and/or uncertainty in survival assessment; 19. Major surgery (as determined by the investigator) or significant trauma within 4 weeks prior to randomization; or elective major surgery planned during the study period. Biopsy for diagnostic purposes is permitted.

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Conditions

The condition(s) this trial relates to.

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 official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  2. 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.

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