Parallel transmit for 7T MRI imaging in epilepsy
| ISRCTN | ISRCTN16452095 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16452095 |
| IRAS number | 322922 |
| Secondary identifying numbers | CPMS 54920, IRAS 322922 |
- Submission date
- 03/06/2024
- Registration date
- 05/06/2024
- Last edited
- 25/03/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Nervous System Diseases
Plain English summary of protocol
Background and study aims
360,000 people have focal epilepsy in the UK, one-third of whom have persistent seizures despite medication. Persistent seizures make it difficult to work, impossible to drive, and carry a high risk of death. Epilepsy surgery transforms lives by stopping seizures in 70% of patients when there is a clear resection target. Current NHS standard of care uses 3T MRI and FDG-PET brain scans to identify surgical targets, but this combination is often inconclusive. 7T MRI is recommended because of enhanced sensitivity, but there are two practical barriers to clinical implementation:
1. Lesions are often in the temporal lobes (areas of the brain) where conventional (single transmit) 7T MRI is obscured by signal drop-outs.
2. No 7T MRI sequences are CE marked for clinical use in epilepsy.
The consensus group recommend the development of parallel transmit 7T MRI to improve the visualisation of lesions in the temporal lobes where conventional (single transmit) 7T MRI can be obscured by signal drop-outs. This study will evaluate the use of parallel transmit 7T MRI sequences to remove these barriers to 7T MRI in hospitals performing epilepsy surgery, offering patient benefits and cost savings. This will provide proof-of-concept for future industry collaboration to seek CE marking of the scanner hardware and sequences for routine clinical implementation, but the current study has no manufacturer involvement and will not directly lead to commercialisation.
Who can participate?
Patients aged over 18 years with drug-resistant focal epilepsy who are being evaluated for surgery and have normal or equivocal 3T MRI brain imaging
What does the study involve?
Participants will undergo a parallel transmit 7T MRI brain scan.
What are the possible benefits and risks of participating?
The researchers hope that the scan will show more information about where in the brain epilepsy is coming from, allowing surgical decisions to be made more accurately. The main risk is that the scan will provide no additional information and will be a waste of time.
Where is the study run from?
Cambridge University Hospitals (UK)
When is the study starting and how long is it expected to run for?
October 2022 to March 2026
Who is funding the study?
Medical Research Council (UK)
Who is the main contact?
Dr Thomas E Cope, thomas.cope@nhs.net
Contact information
Scientific
Department of Neurology
Addenbrooke’s Hospital
Cambridge
CB2 0QQ
United Kingdom
| Phone | +44 (0)1223216759 |
|---|---|
| Thomas.cope@nhs.net |
Study information
| Study design | Non-randomized; Both; Design type: Diagnosis, Imaging, Validation of investigation /therapeutic procedures |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Parallel transmit for 7T MRI imaging in epilepsy |
| Study objectives | Does parallel transmit 7T MRI detect lesions better than 3T MRI, and better than single transmit 7T MRI? |
| Ethics approval(s) | Approved 16/02/2023, Solihull Research Ethics Committee (Equinox House, City Link, East Midlands REC Centre, NG2 4LA, UK; +44 (0)2071048071; solihull.rec@hra.nhs.uk), ref: 23/WM/0008 |
| Health condition(s) or problem(s) studied | Epilepsy |
| Intervention | Suitable patients will be identified by the epilepsy clinical multi-disciplinary team, from the established CUH epilepsy surgery pathway. We anticipate that the primary utility of 7T MRI in these patients will be to detect suspected lesions not detected by a standard clinical MRI, which will usually have been performed on a 3Tesla scanner. Requests for this indication must be made by a consultant neurologist and approved by a consultant neuroradiologist on receipt of the necessary clinical details. There may also be patients in whom a 7T MRI may be deemed beneficial for other indications. For example, it might allow further characterization of a structural abnormality observed at lower field strength, both in terms of nature and precise extent. This may allow more precise surgical planning or pre-surgical electrode positioning. Requests for any such indication must be approved by the epilepsy multi-disciplinary team, before approval by a consultant neuroradiologist. The patient will then be approached by the clinical team, who will explain the 'off-label' nature of 7T imaging, and ask them if they would like to attend for this additional scan (which supplements and does not replace usual clinical care). Only at this stage will the research team be informed of the patient, and then asked to make an appointment for 7T imaging. The patient will attend their appointment, completing the CUH-approved consent form (attached), as well as the usual WBIC safety questionnaires. They will undergo a single scan, lasting approximately 1 hour. Clinical images will then be uploaded to CUH PACS, while research images will be anonymised before transfer to the established WBIC imaging database along with patient age and sex. The clinical team will undertake follow-up and, with the patient's permission, provide the research team with anonymised longitudinal details about the type of epilepsy the patient has, what treatments they receive, and how well they are able to control their seizures both before and after imaging. |
| Intervention type | Other |
| Primary outcome measure | Whether the parallel transmit 7T MRI scan changes the epilepsy multi-disciplinary team's management plan: the MDT management plan is recorded before and after review of 7T, and a decision is made on whether it has changed. |
| Secondary outcome measures | 1. Epilepsy surgical outcomes in terms of seizure freedom and quality of life measures, assessed longitudinally after surgery using Engel and ILAE outcome scales and the Quality of Life in Epilepsy Inventory 2. Correlation between 7T MRI and stereotactic EEG and neuropathology findings |
| Overall study start date | 19/10/2022 |
| Completion date | 31/03/2026 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 35; UK Sample Size: 35 |
| Key inclusion criteria | 1. Age >18 years 2. Drug-resistant focal epilepsy (DRFE), defined as focal epilepsy that remains refractory to treatment with anti-epileptic medication, defined as continuing to have seizures despite adequate trials of two medications over 2 years 3. A desire to have curative surgery (i.e. the patient is in an established epilepsy surgery pathway) 4. A decision by the treating epileptologist that finding a new lesion, or better characterising a lesion poorly visualised at 3T MRI, would make a material difference to patient treatment options |
| Key exclusion criteria | 1. Pregnancy 2. The presence of non-MRI-safe metal implants 3. Implanted medical devices not certified as compatible with ultrahigh-field MRI (e.g.cardiac pacemakers) 4. Lack of mental capacity to consent to study involvement 5. Severe claustrophobia |
| Date of first enrolment | 30/06/2023 |
| Date of final enrolment | 31/03/2025 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
Hills Road
Cambridge
CB2 0QQ
United Kingdom
De Crespigny Park
Denmark Hill
London
SE5 8AB
United Kingdom
Edgbaston
Birmingham
B15 2TH
United Kingdom
Sponsor information
Hospital/treatment centre
Cambridge Biomedical Campus
Hills Road
Cambridge
CB2 0QQ
England
United Kingdom
| Phone | +44 (0)1223 217418 |
|---|---|
| CUH.research@nhs.net | |
| Website | http://www.cuh.org.uk/ |
"ROR" |
https://ror.org/04v54gj93 |
Funders
Funder type
Research council
Government organisation / National government
- Alternative name(s)
- Medical Research Council (United Kingdom), UK Medical Research Council, MRC
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/03/2027 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be available upon request from Prof. Christopher Rodgers (ctr28@cam.ac.uk) |
Editorial Notes
25/03/2025: The overall study end date was changed from 31/03/2025 to 31/03/2026, and the intention to publish date was changed from 31/03/2026 to 31/03/2027.
03/06/2024: Study's existence confirmed by the NIHR.
