Plain English Summary
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
Trial website
Contact information
Type
Scientific
Primary contact
Mr David Bird
ORCID ID
Contact details
Radiotherapy Physics
Medical Physics and Engineering
Level 1
Bexley Wing
St James's University Hospital
Beckett Street
Leeds
LS9 7TF
United Kingdom
+44 (0)1132067937
david.bird3@nhs.net
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
CPMS 39102, IRAS 243334
Study information
Scientific title
MANTA-RAY: MRI-only treAtmeNT planning for Anal and Rectal cAncer radiotherapY
Acronym
MANTA-RAY
Study hypothesis
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
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
Study design
Interventional non-randomized study
Primary study design
Interventional
Secondary study design
Non randomised study
Trial setting
Hospitals
Trial type
Diagnostic
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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 names
MRI
Primary outcome measure
Phase 1 - Quantification of radiotherapy treatment plan measured by dosimetric difference between CT and synthetic-CT (generated from MRI data) datasets
Phase 2 - Quantification of differences in target volumes and reduction in dose to organs at risk for CT vs MRI-only based radiotherapy treatment plans
Phase 3 - Quantification of systematic and random errors attributable to use of MRI or sCT data vs CT data for patient treatment position registration using CBCT
Secondary outcome measures
None
Overall trial start date
01/05/2018
Overall trial end date
01/05/2021
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Planned Sample Size: 60; UK Sample Size: 60
Participant exclusion criteria
Standard clinical contra-indications to MRI scanning (claustrophobia, pacemaker).
Recruitment start date
28/09/2018
Recruitment end date
01/12/2020
Locations
Countries of recruitment
United Kingdom
Trial participating centre
St James's University Hospital
Leeds Teaching Hospitals NHS Trust
Beckett Street
Leeds
LS9 7TF
United Kingdom
Sponsor information
Organisation
Leeds Teaching Hospitals NHS Trust
Sponsor details
St. James's University Hospital
Beckett Street
Leeds
LS9 7TF
United Kingdom
+44 (0)113 2060469
anne.gowing@nhs.net
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Government
Funder name
NIHR Academy; Grant Codes: ICA-CDRF-2017-03-005
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
National Institute for Health Research (NIHR) (UK)
Alternative name(s)
NIHR
Funding Body Type
unknown
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer-reviewed journal.
IPD sharing statement:
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.
Intention to publish date
01/05/2022
Participant level data
Not expected to be available
Basic results (scientific)
Publication list