New MRI technique could predict memory loss after brain radiation
NCT ID NCT03606421
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.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 110 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2018
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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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
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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: * 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
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University Health Network
Toronto, Ontario, L4W4C2, Canada
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Other studies related to the condition(s) this trial covers.
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