Active — Not RecruitingNot Applicable

Measuring and Mapping Cognitive Decline After Brain Radiosurgery

United Kingdom80 participantsStarted 2024-06-21

Plain-language summary

Background Stereotactic Radiosurgery (SRS) is a localised radiotherapy treatment for patients with brain metastases or other benign tumours in the brain, like meningiomas. The Investigators do not currently know if, or how much, SRS affects brain function. Patients with brain tumours do not get tested routinely for their brain function. Understanding short- and long-term side-effects is important for SRS. Brain metastases patients have short life expectancies (6-months to 1-year). However, meningioma patients can live 10 years or more. SRS is used to treat both. The Montreal Cognitive Assessment will be used to test the participants' brain function. Quality-of-life questionnaires QLQ-C30 and BN20 will also be used to assess the participants' physical and mental wellbeing . These are specific for patients with brain cancer. Why is it important This study aims to identify areas in the brain that relate to changes in brain function after SRS. These areas can then have the radiation dose reduced to them in future patients, hoping to minimise side-effects. Research Question Which regions of the brain contribute to a decline in brain function following SRS. Study Design This is a single centre observational study with prospective and retrospective collection of data. This study will look at two groups of patients: Group1: Patients will complete the MoCA and two quality-of-life questionnaires before the treatment and every 3 months for a year. Group2: Patients will complete the MoCA and two quality-of-life questionnaires once. The investigators will use these tests, MRI scans and the SRS treatment plan to identify areas of the brain that are responsible for any problems with the participants' brain function. The participants for Group 1 will be recruited from the SRS Clinics, at City Campus, Nottingham University Hospitals NHS Trust. The participants for Group 2 will be identified through the Mosaiq Oncology Information System. This pilot study is funded by the Midlands Mental Health and Neurosciences Network.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria Prospective Cohort Patients will be eligible for inclusion only if ALL of the following criteria apply: * Age: above 18 years, no upper limit * Diagnosis of brain metastases or meningioma, where the treatment is going to be stereotactic radiosurgery * Karnofsky Performance Status (KPS) ≥70 * Established diagnosis of cancer with absent or controllable primary disease * Tumour volume of less than 20cc * Life expectancy of more than 6 months * Able to give informed consent Exclusion criteria Prospective Cohort * Previous RT to the brain, including SRS * Previous surgery to the brain * Not willing or not able to give informed consent Inclusion criteria Retrospective Cohort Patients will be eligible for inclusion only if ALL of the following criteria apply: * Age: above 18 years, no upper limit * Diagnosis of meningioma * Previous SRS treatment at least 1 year prior to inclusion in the study * Most recent MRI scan (within 1 year) shows stable appearances * Able to give informed consent Exclusion criteria Retrospective Cohort * Previous RT to the brain, excluding SRS * Previous surgery to the brain * Not willing or not able to give informed consent

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change from Baseline to neurocognitive function and Quality of Life at 6 months

Timeframe: 6 months

Doses related to neurocognitive symptoms

Timeframe: 6 months

Trial details

NCT IDNCT06466720

SponsorUniversity of Nottingham

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-06-30

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