Planning using MRI for anal and rectal cancer radiotherapy treatment
| ISRCTN | ISRCTN82734641 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN82734641 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Integrated Research Application System (IRAS) | 243334 |
| Protocol serial number | CPMS 39102, IRAS 243334 |
| Sponsor | Leeds Teaching Hospitals NHS Trust |
| Funders | NIHR Academy; Grant Codes: ICA-CDRF-2017-03-005, National Institute for Health Research (NIHR) (UK) |
- Submission date
- 27/01/2020
- Registration date
- 12/03/2020
- Last edited
- 19/05/2023
- Recruitment status
- Suspended
- Overall study status
- Completed
- Condition category
- Cancer
Plain English summary of protocol
Background and study aims
Almost half of cancer patients undergo radiotherapy as part of their treatment. Currently radiotherapy treatment planning involves using a CT scan to maximise radiation to the cancer whilst minimising radiation dose to healthy tissue. For many cancers the extent of the tumour is seen much better on Magnetic Resonance Imaging (MRI). This study will assess whether MRI can replace CT for radiotherapy planning for ano-rectal cancers.
Who can participate?
Adult patients (> 18 years) undergoing radiotherapy at Leeds Teaching Hospitals NHS Trust or the Northern Centre for Cancer Care (NHS) for anal and rectal cancers.
What does the study involve?
Patients who are already receiving radiotherapy as part of their treatment undergoing radiotherapy in Leeds Cancer Centre will be invited to participate in an imaging study where an additional MRI scan is obtained after informed consent have been taken. This study will have no impact on the participant’s treatment. The MRI scan will be used to compare the new method of treatment planning with the current method used routinely in patient care.
What are the possible benefits and risks of participating?
There are no direct benefits to taking part, however taking part will help patients in the future. There are some limited risks of taking part, associated with having an MRI scan. All risks will be clearly explained in the information sheets for the study.
Where is the study run from?
Leeds Teaching Hospitals NHS Trust (UK)
The researchers are collaborating with the Northern Centre for Cancer Care (NCCC) based at Freeman Hospital Newcastle-upon-Tyne, the Calvary Mater Newcastle Hospital (Australia), The Australian e-Health Research Centre (Royal Brisbane and Women's Hospital), a consortium of UK institutions supported by Cancer Research UK Centres Network Accelerator Award Grant (A21993) (ART-NET) and two medical companies: Spectronics Medical AB (Sweden) and Philips Healthcare (The Netherlands), to help develop this way of planning treatments. NCCC will participate in recruitment, the other collaborators will participate in the analysis of the anonymised data.
When is the study starting and how long is it expected to run for?
August 2018 to April 2021
Who is funding the study?
National Institute for Health Research (NIHR) (UK)
Who is the main contact?
David Bird
david.bird3@nhs.net
Contact information
Scientific
Radiotherapy Physics, Medical Physics and Engineering
Level 1, Bexley Wing
St James's University Hospital
Beckett Street
Leeds
LS9 7TF
United Kingdom
| Phone | +44 (0)1132067937 |
|---|---|
| david.bird3@nhs.net |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Interventional non-randomized study |
| Secondary study design | Non randomised study |
| Study type | Participant information sheet |
| Scientific title | MANTA-RAY: MRI-only treAtmeNT planning for Anal and Rectal cAncer radiotherapY |
| Study acronym | MANTA-RAY |
| Study objectives | MR-only treatment planning is technically accurate, clinically implementable and has potential benefit for external beam radiotherapy treatments for ano-rectal cancer patients. |
| Ethics approval(s) | Approved 01/08/2018, London - Surrey Research Ethics Commitee (Level 3, Block B, Whitefriars, Lewins Mead, Bristol, BS1 2NT, UK; +44 (0)207 1048058; nrescommittee.secoast-surrey@nhs.net), ref:19/LO/1298 |
| Health condition(s) or problem(s) studied | Colorectal Cancer |
| Intervention | This is technical process which will be carried out to assess whether MRI scans can be used to plan radiotherapy treatments, instead of the current standard of using CT scans, in patients with anal and rectal cancers who are due to undergo radiotherapy. This study will be investigating the clinical implementability of the whole treatment pathway for anal and rectal cancer patients including it's potential benefit. A cohort of Leeds Cancer Centre and Northern Centre for Cancer Care patients due to undergo radiotherapy will have an additional, research only, MRI scan acquired. These patients will be identified by their clinical team or the research team as suitable when attending radiotherapy outpatient clinics. Suitable patients will be provided with a patient information sheet about the study and at the next visit to the radiotherapy clinic written informed consent will be obtained by the clinical or research team. The additional research MRI scan will be scheduled to coincide with radiotherapy appointments so that patients do not routinely need to come for an additional visit. All patient data will then be anonymised before analysis. No IV contrast will be given with the MRI scans. Anonymised patient MRI and CT scans from the Leeds Cancer Cencer and Northern Centre for Cancer Care patients will be shared under Information Governance authorisation to develop the technical process. The researchers will not be collecting nor sharing any clinical information on patients. |
| Intervention type | Device |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | MRI |
| Primary outcome measure(s) |
Phase 1 - Quantification of radiotherapy treatment plan measured by dosimetric difference between CT and synthetic-CT (generated from MRI data) datasets |
| Key secondary outcome measure(s) |
None |
| Completion date | 01/05/2021 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 60 |
| Key inclusion criteria | 1. Adult patients (>18 years) undergoing radiotherapy at Leeds Teaching Hospitals NHS Trust or the Northern Centre for Cancer Care (NHS) for anal and rectal cancers 2. Ability to give written informed consent |
| Key exclusion criteria | Standard clinical contra-indications to MRI scanning (claustrophobia, pacemaker). |
| Date of first enrolment | 28/09/2018 |
| Date of final enrolment | 01/12/2020 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Beckett Street
Leeds
LS9 7TF
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not expected to be made available |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are not expected to be made available due to patient confidentially and trust data-sharing policy as agreed in the study REC/HRA approval. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No | ||
| Interim results article | Multicentre, deep learning, synthetic-CT generation for ano-rectal MR-only radiotherapy treatment planning | 01/03/2021 | 19/05/2023 | Yes | No |
| Interim results article | Patient position verification in magnetic-resonance imaging only radiotherapy of anal and rectal cancers | 01/07/2021 | 19/05/2023 | Yes | No |
| Interim results article | The benefit of MR-only radiotherapy treatment planning for anal and rectal cancers: A planning study | 22/10/2021 | 19/05/2023 | Yes | No |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
19/05/2023: Publication references added.
24/04/2020: Due to current public health guidance, recruitment for this study has been paused.
28/01/2020: Trial’s existence confirmed by National Institute for Health Research (NIHR)
