Feasibility of amide proton transfer imaging in children and adolescents with brain tumours
| ISRCTN | ISRCTN41243307 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN41243307 |
| IRAS number | 162706 |
| Secondary identifying numbers | IRAS 162706 |
- Submission date
- 21/01/2022
- Registration date
- 06/03/2022
- Last edited
- 29/04/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Plain English summary of protocol
Background and study aims
Gliomas are brain tumours that start in glial cells. In children and adolescents diagnosed with gliomas, MRI scans are used to follow up patients which can be challenging, particularly when assessing a non-enhancing tumour. APT-CEST is a technique that can show an increased signal in non-enhancing parts of the tumour and the aim of this study is to correlate the APT-CEST signal with choline uptake as a marker of tumour activity.
Who can participate?
Children and adolescents aged 12-20 years being treated for glioma
What does the study involve?
Participation will involve the patient undergoing a PET-MRI scan. The participant will be injected with a radio-isotope named choline followed by an MRI scan. The MRI will be slightly longer than a normal diagnostic MRI at about 45 minutes. Following the PET-MRI scan, the patient will be free to go and will be followed up in clinic with their normal doctor.
What are the possible benefits and risks of participating?
The benefit for the patient will be an improved understanding of their tumour. The study will require extra time for scanning.
Where is the study run from?
University College London Hospitals NHS Foundation Trust (UK)
When is the study starting and how long is it expected to run for?
September 2015 to March 2020
Who is funding the study?
UCLH Biomedical Research Centre (UK)
Who is the main contact?
Dr Harpreet Hyare
harpreet.hyare@nhs.net
Contact information
Principal Investigator
20 Porchester Terrace
London
W2 3TL
United Kingdom
| Phone | +44 (0)7939061494 |
|---|---|
| harpreet.hyare@nhs.net |
Study information
| Study design | Observational feasibility study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Case series |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Participant information sheet | Not available in web format, please use the contact details to request a participation information sheet. |
| Scientific title | Feasibility of amide proton transfer chemical exchange saturation transfer in paediatric, teenage and young adult gliomas |
| Study objectives | Amide proton transfer (APT)-chemical exchange saturation transfer (CEST) demonstrated an elevated signal in brain tumours compared to normal-appearing brain tissue. |
| Ethics approval(s) | Approved 22/02/2016, London-Bromley Research Ethics Committee (Level 3, Block B, Whitefriars, Lewins Mead, Bristol, BS1 2NT, UK; +44 (0)207 104 8105; bromley.rec@hra.nhs.uk), REC ref: 16/LO/0276 |
| Health condition(s) or problem(s) studied | Glioma |
| Intervention | The participant is recruited from clinic by their normal doctor and is asked to undergo a PET-MRI study. The patient is given an information sheet and If the patient agrees, they are booked for a scan in the Nuclear Medicine Department. On the day of the scan, the patient is consented. The patient will have a canal fitted and be injected with radioactive choline. After 60 minutes, they will undergo a PET-MRI scan which is slightly longer than a normal MRI scan at approximately 45 minutes. The patient is then free to go and will be followed up by their normal doctor in clinic. |
| Intervention type | Other |
| Primary outcome measure | Glioma tumour cell proliferation measured using amide proton transfer chemical exchange saturation transfer (APT-CEST) and 18F-fluoromethylcholine (18F-choline) positron emission tomography (PET) standardised uptake value (SUV) at baseline |
| Secondary outcome measures | There are no secondary outcome measures |
| Overall study start date | 01/09/2015 |
| Completion date | 01/03/2020 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Sex | Both |
| Target number of participants | 10 |
| Total final enrolment | 10 |
| Key inclusion criteria | Patients aged 12-20 years undergoing treatment for glioma |
| Key exclusion criteria | 1. Pregnant 2. Other cancer |
| Date of first enrolment | 01/04/2016 |
| Date of final enrolment | 01/03/2020 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
London
NW1 2PG
United Kingdom
Sponsor information
Hospital/treatment centre
250 Euston Road
London
WC1N 3PG
England
United Kingdom
| Phone | +44 (0)8451555000 |
|---|---|
| semerton@nhs.net | |
| Website | https://www.uclh.nhs.uk/Pages/home.aspx |
"ROR" |
https://ror.org/042fqyp44 |
Funders
Funder type
Research organisation
Private sector organisation / Universities (academic only)
- Alternative name(s)
- NIHR University College London Hospitals Biomedical Research Centre, University College London Hospitals Biomedical Research Centre, UCLH/UCL Biomedical Research Centre, NIHR University College London Hospitals BRC, NIHR BRC, UCL, UCLH BRC
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 01/03/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Peer-reviewed journal publication. Additional documents are not available. |
| IPD sharing plan | The data-sharing plans for the current study are unknown and will be made available at a later date. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
29/04/2022: The sponsor contact has been updated.
03/03/2022: Trial's existence confirmed by the London-Bromley Research Ethics Committee.
