Measuring and Mapping Cognitive Decline After Brain Radiosurgery
NCT Number: NCT06466720
Acronym: CoDeB-Rad
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Brain Metastases|Meningiomas|Stereotactic Radiosurgery|Cognitive Decline|Quality of Life|SRS
Interventions: BEHAVIORAL: Neurocognitive testing|BEHAVIORAL: Quality of Life questionnaire|RADIATION: Stereotactic radiosurgery
Sponsor: University of Nottingham
Collaborators: Wellcome Trust
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 80
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-06-10
Completion Date: 2026-02-28
Locations: Nottingham University Hospitals NHS Trust, Nottingham, Nottinghamshire, NG5 1 PB, United Kingdom

Summary:
Background Stereotactic Radiosurgery (SRS) is a localised radiotherapy treatment for patients with brain metastases or other benign tumours in the brain, like meningiomas. We 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.

We will use the Montreal Cognitive Assessment (MoCA) to test your brain function. We will use quality-of-life questionnaires QLQ-C30 and BN20. These are specific for patients with brain cancer. They include questions about physical and mental wellbeing.

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 your treatment and every 3 months for a year.

Group2: Patients will complete the MoCA and two quality-of-life questionnaires once.

We will use these tests, your MRI scans and your SRS treatment plan to identify areas of the brain that are responsible for any problems with your 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.

Primary Outcome Measures: 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 Outcome Measures: Recruitment feasibility, The number of patients screened versus the number of patients recruited will be recorded along with any reasons for non-participation, 1.5 years|Patient reported symptoms vs symptoms identified by neurocognitive testing, • Do patient reported symptoms relate to those identified from neurocognitive testing., At baseline and every 3 months
Other Outcome Measures: Areas of the brain related to neurocognitive function, • Geographical correlation of areas in the brain with change in neurocognitive function as identified by Voxel based lesion symptom mapping, 6 months|Identification of radiosensitive structures in the brain, • Identification of brain structures most affected by radiation via differences in the cognitive testing., 6 months