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New MRI technique could predict memory loss after brain radiation

NCT ID NCT03606421

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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 11, 2026 · Updated 1 time

Summary

This study follows 110 people with brain metastases who are receiving either focused or whole-brain radiation. Researchers use advanced MRI scans and memory tests before treatment and for two years after to see if the scans can predict thinking and memory problems. The goal is to find early warning signs of cognitive decline, not to test a new treatment.

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.

Participants

About 110 people

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

Started

Oct 2018

Expected to finish

Dec 2026

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.

Who is studied

Patients with brain metastases, at least one of which is appropriate for radiotherapy

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: * Patients with brain metastases will be included in this study. Patients with known malignancies but without brain metastases, or patients with primary brain tumors are not eligible for enrollment. * MRI confirmed 1-10 lesions. Each lesion must not be intended for resection. * No prior radiation therapy for brain tumours. * For patients enrolled to arm B, ability to tolerate RespirAct. Based on studies in patients with severe cerebrovascular disease, an 8 - 16% drop-out rate at the time of the first exposure to RespirAct CVR testing is expected \[9\]. The fourth generation of this device has been associated with increased tolerability secondary to elimination of a physical rebreathing circuit replaced by a digital re-breath analog. This improvement is expected to achieve a drop-out rate significantly below 10%. * Patients must have a GPA greater than or equal to 1.0. * Patients must be able to provide informed consent. Patient consent must be appropriately obtained in accordance with applicable local and regulatory requirements. Each patient must sign a consent form prior to enrollment in the trial to document their willingness to participate. * Patients must have sufficient fluency in English and sufficient motor and visual functioning (corrected or assisted as required) to complete the NCF-A battery. * Patients must be accessible for treatment, AE assessment and follow- up. * Limit to KPS ≥ 70 for patients in arm B; no limit for arm A * Women/men of childbearing potential must have agreed to use a highly effective contraceptive. Women of childbearing potential will have a pregnancy test to determine eligibility. Exclusion Criteria: * Treatment plan respecting normal tissue tolerances using dose fractionation specified within the protocol cannot be achieved. * Pregnant patients will be excluded from this study. * Prior cranial radiotherapy * Inability to complete MRI with contrast of the head, or a known allergy to gadolinium * Metastatic germ cell tumor, small cell carcinoma, or lymphoma or any primary brain tumor. * Patients with known malignancies but without brain metastases. * Image Findings * Widespread definitive leptomeningeal metastasis * A brain metastasis that is located ≤ 2 mm of the optic chiasm * Evidence of midline shift * Fourth ventricular narrowing, concerning for hydrocephalus * Patients who have undergone surgical resection of brain tumor are not eligible for enrollment.

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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.

Contacts and locations

Locations

  • University Health Network

    Toronto, Ontario, L4W4C2, Canada

More trials for these conditions

Other studies related to the condition(s) this trial covers.