Measuring and Mapping Cognitive Decline After Brain Radiosurgery: a Pilot Study

Status: Recruiting
Location: See location...
Intervention Type: Radiation, Behavioral
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

⁃ 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

⁃ 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

Locations
Other Locations
United Kingdom
Nottingham University Hospitals NHS Trust
RECRUITING
Nottingham
Contact Information
Primary
AB Bangiri
anna.bangiri1@nottingham.ac.uk
00441157484240
Time Frame
Start Date: 2024-06-21
Estimated Completion Date: 2026-02-28
Participants
Target number of participants: 80
Treatments
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.
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.
Sponsors
Collaborators: Wellcome Trust
Leads: University of Nottingham

This content was sourced from clinicaltrials.gov