Exploring brain and cognitive changes after radiation for brain metastases
Use of Novel MRI Techniques Before and After Brain Radiotherapy With Parallel Assessments of Neurocognitive Function
This study is testing how two different types of radiation treatment for brain metastases affect thinking and memory over two years.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 110 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Health Network, Toronto Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Toronto, Ontario) |
| Trial ID | NCT03606421 on ClinicalTrials.gov |
What this trial studies
This observational study involves patients with brain metastases who will be assigned to receive either stereotactic radiosurgery (SRS) or whole-brain radiation therapy (WBRT). The study aims to assess neurocognitive function before and for two years after treatment, while also evaluating a novel MRI protocol to identify potential biomarkers for cognitive decline. By comparing the two treatment arms, the study seeks to understand the impact of radiation on brain and cognitive health in these patients.
Who should consider this trial
Good fit: Ideal candidates are patients with 1-10 MRI-confirmed brain metastases who have not received prior radiation therapy and can provide informed consent.
Not a fit: Patients with primary brain tumors or those without brain metastases will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and management of neurocognitive dysfunction in patients undergoing radiation therapy for brain metastases.
How similar studies have performed: While this approach is novel in its specific focus on neurocognitive function post-radiation, similar studies have explored cognitive outcomes in brain metastases, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Toronto, Ontario
- University Health Network — Toronto, Ontario, Canada (Recruiting)
Study contacts
- Study coordinator: David Shultz, MD
- Email: david.shultz@rmp.uhn.ca
- Phone: 416-946-4501
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.