Measuring and Mapping Cognitive Decline After Brain Radiosurgery

NCT06466720 | Active Not Recruiting

• 1 other identifier: 24016
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Brain Metastases; Meningiomas; Stereotactic Radiosurgery; Cognitive Decline; Quality of Life; SRS

Keywords

Brain metastases; Meningiomas; Stereotactic Radiosurgery; SRS; Cognitive Decline; Quality of Life

Outcome Measures

Primary Outcomes (2)

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

  Significant changes in neurocognitive function and Quality of Life at 6 months compared to baseline.The scale ranges from 0-100 with 0 signifying a worse quality of life and 100 signifying excellent quality of life for the participants. The cognitive function scale ranges from 0-30 with 30 signifying non-impaired cognitive function.

  6 months

• Doses related to neurocognitive symptoms

  • Doses above which the lesion symptom mapping identifies areas of the brain relevant to neurocognitive symptoms at 6 months.

  6 months

Secondary Outcomes (2)

• Recruitment feasibility

  1.5 years

• Patient reported symptoms vs symptoms identified by neurocognitive testing

  At baseline and every 3 months

Other Outcomes (2)

• Areas of the brain related to neurocognitive function

  6 months

• Identification of radiosensitive structures in the brain

  6 months

Study Arms (2)

Prospective

Patients with brain metastases and meningiomas that are eligible for SRS treatment will be included in the prospective arm of the trial. The patients will have neurocognitive testing in the form of the Montreal Cognitive Assessment (MoCA) and will answer two Quality of Life questionnaires (QLQs) by EORTC QLQ-C30 and BN20). The baseline visit will happen before they start their SRS treatment. The patients will be seen an additional 4 times, at 3, 6, 9 and 12 months after radiotherapy treatment. During each visit they will complete the MoCA and the QLQs. During the first follow up appointment they will also be asked to think back to before they had the treatment and answer the QLQs based on that.

Behavioral: Neurocognitive testing; Behavioral: Quality of Life questionnaire; Radiation: Stereotactic radiosurgery

Retrospective

Patients with meningiomas that have received SRS treatment more than a year ago will be included in the retrospective arm of the trial. The patients will have neurocognitive testing in the form of the Montreal Cognitive Assessment (MoCA) and will answer two Quality of Life questionnaires (QLQs) by EORTC QLQ-C30 and BN20) once. They will also be asked to think back to before they had the treatment and answer the QLQs based on that.

Behavioral: Neurocognitive testing; Behavioral: Quality of Life questionnaire; Radiation: Stereotactic radiosurgery

Interventions

Neurocognitive testing BEHAVIORAL

The MoCA is a brief tool developed to screen mild cognitive impairment and has been validated in patients aged 55-85 years old. It has been tested and validated in patients with brain metastases, and its acceptability has been tested in the general brain tumour population. The paper version of the MoCA is available in nearly 100 languages. The online version is available currently in 5 languages.

Also known as: Montreal Cognitive Assessment

Prospective; Retrospective

Quality of Life questionnaire BEHAVIORAL

The EORTC-QLQ-C30 is a quality-of-life questionnaire that was developed by the European Organisation for Research and Treatment of Cancer (EORTC) for use in clinical trials. It is a 30-item questionnaire that incorporates the following five scales: physical, role, cognitive, emotional and social. It has also been validated and is available in more than 100 languages. The EORTC-QLQ-BN20 is a questionnaire that was developed for use specifically with patients that have brain cancer. The BN20 is a 20-item questionnaire and addresses four different scales (multi-item): future uncertainty, visual disorder, motor dysfunction and communication deficit. There are seven items that assess physical symptoms: headaches, seizures, drowsiness, hair loss, itchy skin, weakness of legs and bladder control. The questionnaire has been validated in over 15 languages. The two questionnaires are meant to complement each other when used in patients with brain cancer.

Also known as: QLQ-C30, QLQ-BN20

Prospective; Retrospective

Stereotactic radiosurgery RADIATION

This is a Standard of Care treatment for all the patients that will be recruited in both cohorts. Stereotactic radiosurgery will be delivered to one or more sites and in the prospective cohort can be delivered more than once.

Also known as: SRS

Prospective; Retrospective

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The population is based within the East Midlands, United Kingdom. The East Midlands Stereotactic Radiosurgery (SRS) service covers Nottinghamshire, Derbyshire, Lincolnshire and Leicestershire. Any patients that are eligible for SRS (prospective cohort) or has already been treated with SRS (retrospective cohort) and also fulfil the eligibility criteria of the study will be invited to take part in the study. Patients will be recruited through the SRS clinics taking place at City Campus, Nottingham University Hospitals NHS Trust.

You may qualify if:

• 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

You may not qualify if:

• Previous RT to the brain, including SRS
• Previous surgery to the brain
• Not willing or not able to give informed consent
• Age: above 18 years, no upper limit
• Diagnosis of meningioma
• Most recent MRI scan (within 1 year) shows stable appearances
• Able to give informed consent
• Previous RT to the brain, excluding SRS
• Previous surgery to the brain
• Not willing or not able to give informed consent

Sponsors & Collaborators

• University of Nottingham: lead
• Wellcome Trust: collaborator

Study Sites (1)

Nottingham University Hospitals NHS Trust

Nottingham, Nottinghamshire, NG5 1 PB, United Kingdom

Location

Related Publications (22)

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• Brown PD, Jaeckle K, Ballman KV, Farace E, Cerhan JH, Anderson SK, Carrero XW, Barker FG 2nd, Deming R, Burri SH, Menard C, Chung C, Stieber VW, Pollock BE, Galanis E, Buckner JC, Asher AL. Effect of Radiosurgery Alone vs Radiosurgery With Whole Brain Radiation Therapy on Cognitive Function in Patients With 1 to 3 Brain Metastases: A Randomized Clinical Trial. JAMA. 2016 Jul 26;316(4):401-409. doi: 10.1001/jama.2016.9839.

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• Bangiri, A., Horobin, A., Baker, J. et al. Co-production as the ultimate goal; an incentive or discouragement?. Res Involv Engagem 11, 147 (2025). https://doi.org/10.1186/s40900-025-00812-1

  RESULT

• Bangiri A, Horobin A, Baker J, Pszczolkowski S, Thust S, Morgan PS. Outcomes of patient and public involvement in the development of the Cognitive Decline after Brain Radiosurgery (CoDe B-Rad) study: refining the research question and methodology. BMJ Open. 2025 Jun 26;15(6):e094788. doi: 10.1136/bmjopen-2024-094788.

  PMID: 40578862 RESULT

Related Links

• NHS Website, MRI Scan MRI scan - NHS (www.nhs.uk) , page last visited on 12/02/2024

MeSH Terms

Conditions

Brain Neoplasms; Meningioma; Cognitive Dysfunction

Interventions

Mental Status and Dementia Tests; Radiosurgery

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms, Nerve Tissue; Neoplasms by Histologic Type; Neoplasms, Vascular Tissue; Meningeal Neoplasms; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Neuropsychological Tests; Psychological Tests; Behavioral Disciplines and Activities; Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Paul S Morgan, Professor of Medical Physics

  University of Nottingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2024
• First Posted: June 20, 2024
• Study Start: June 21, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)