Condition category
Cancer
Date applied
27/01/2020
Date assigned
12/03/2020
Last edited
24/04/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Suspended

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

http://www.leedsth.nhs.uk/home/

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

government organisation

Funding Body Subtype

National government

Location

United Kingdom

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

Publication citations

Additional files

Editorial Notes

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)