ISRCTN ISRCTN51246892
DOI https://doi.org/10.1186/ISRCTN51246892
Secondary identifying numbers C/33/2014
Submission date
17/11/2015
Registration date
30/11/2015
Last edited
20/02/2024
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English Summary

http://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-study-looking-at-using-mpmri-scans-in-staging-and-treatment-decisions-for-ovarian-cancer-mroc

Contact information

Miss Amanda Bigault
Public

Cancer Research UK Imperial Centre: Clinical Trials Section / Imperial Clinical Trials Unit – Cancer
Department of Surgery and Cancer
Imperial College London
3rd Floor Radiotherapy Building
Hammersmith Hospital Campus
Du Cane Road
London
W12 0NN
United Kingdom

Phone +44 (0)20 7589 5111
Email mroc@imperial.ac.uk
Prof Andrea Rockall
Scientific

1st Floor, ICTEM building
Hammersmith Hospital Campus
Du Cane Road
London
W12 0NN
United Kingdom

Study information

Study designMulti-centre diagnostic accuracy trial
Primary study designObservational
Secondary study designCross sectional study
Study setting(s)Hospital
Study typeDiagnostic
Participant information sheet Not available in web format, please use the contact details to request a patient information sheet
Scientific titleThe impact of multiparametric MRI on the staging and management of patients with suspected or confirmed ovarian cancer
Study acronymMROC
Study hypothesisThe aim of this study is to evaluate the possibility of mpMRI providing an improved radiological assessment for the classification and delineation of the extent of disease for patients with suspected ovarian cancer compared to standard of care CT assessment, potentially facilitating more accurate decisions regarding patient management by the MDT.
Ethics approval(s)Committee: London – City Road and Hampstead, 03/12/2015, REC Ref: 15/LO/1904
ConditionOvarian cancer
Intervention645 women with suspected or confirmed OC will be recruited onto the study and will have an mpMRI scan in addition to the standard of care CT. After all the scans have been obtained, the MDT at the site (the medical team who make decisions about a patients care) will then determine the stage and treatment plan for the patient based upon the CT alone, as per standard practice guidelines. Any critical findings from the mpMRI will be revealed to the MDT after they have made an initial decision; the patient will then progress with treatment, as decided.

The local MDT will then meet again for a further two meetings. In the second meeting they will produce theoretical treatment plans based upon the mpMRI alone and then another using a combination of the mpMRI and CT scan. This will not affect how the patient is treated. The third meeting will be 6 months after the patient was first enrolled onto the trial. At this meeting all available clinical and imaging information will be reviewed and the MDT will determine what stage the patient was at and what the optimal treatment plan would have been.

Anonymised copies of the CT and mpMRI scans will also be sent to MDTs at two other external NHS hospitals. They will hold three separate meetings that will occur three months apart. They will form theoretical treatment plans based upon the CT alone, mpMRI alone and CT and mpMRI combined and the order in which they report them will be randomly allocated. These treatment plans will not have any effect on patient management. The purpose of doing this is to compare how a patients treatment is decided based on whether MDTs are looking at the CT scan, the mpMRI scan or both and also to see if these decisions are the same between different MDTs.

During the study, patients will only attend one extra appointment for the mpMRI, all other data will be provided by their medical records and the MDTs. Participants will also be given the option to donate tissue and blood samples, which would be obtained during surgery at participating hospitals who routinely collect fresh-frozen tissue.
Intervention typeOther
Primary outcome measureComparison of the diagnostic accuracy in detecting advanced cancer stage based on radiological staging of women with suspected or confirmed ovarian cancer between mpMR with CT and CT alone
Secondary outcome measures1. Difference in proportion of patients avoiding unsuccessful patient management mostly resulting from (unnecessary) cancer surgery. mpMRI and CT will be compared against the reference standard for patient management decisions to determine unsuccessful treatment
2. Comparison of image findings determining surgical resectability and the MDT decisions determining surgical resectability, per patient
3. Comparison of incremental cost and cost effectiveness accounting for categorisation into final surgical outcome, treatment costs & patient outcomes
4. Difference in sensitivity and specificity of peritoneal disease of diagnostic accuracy, per patient and per location
5. Comparison of MDT plans between local and external MDTs for treatment choice, ITU stay, length of operation, surgical expertise needed, per patient

Sub-Study Objectives:
1. Inter-observer agreement of mpMRI interpretation/reading for accurate diagnosis of referral for sites of disease and cancer stage; per patient and per location
2. Comparison of mpMRI to conventional MRI (analyse for primary outcome and secondary outcomes 1 and 2 only) in order to determine incremental benefit
Overall study start date01/12/2015
Overall study end date08/02/2023

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexFemale
Target number of participants645
Total final enrolment648
Participant inclusion criteria1. Written (signed and dated) informed consent* prior to mpMRI scan^ and judged capable of co-operating with study requirements during treatment and follow-up
2. Aged 18 years or over
3. Suspected ovarian, fallopian tube or primary peritoneal cancer. This can be contingent on imaging findings (either on ultrasound or CT) and/or a Risk Malignancy Index Score (RMI) greater than 250
4. Being considered for up-front surgery or for interval debulking surgery following neoadjuvant chemotherapy (after 3 to 5 cycles) via the “NHS Cancer Pathway”
5. Considered fit for surgery (by MDT or patient’s surgeon)
*A patient can be enrolled based on verbal consent with written consent to be obtained prior to the mpMRI scan
Participant exclusion criteria1. Known contraindication to MRI (e.g. claustrophobia, ferrous implants, cardiac pacemaker, inability to lie flat)
2. Known pregnancy
3. Medical or psychiatric illness that renders the patient unsuitable or unable to give informed consent
4. Unable to undergo a CT scan with IV contrast due to allergy, renal failure or any other cause
Recruitment start date01/03/2016
Recruitment end date30/12/2020

Locations

Countries of recruitment

  • England
  • Scotland
  • United Kingdom

Study participating centres

Hammersmith Hospital
Du Cane Road
London
W12 0NN
United Kingdom
The Royal Marsden Hospital
Fulham Road
London
SW3 6JJ
United Kingdom
University College Hospital
235 Euston Road
London
NW1 2BU
United Kingdom
Beatson West of Scotland Cancer Centre
1053 Great Western Road
Glasgow
G12 0YN
United Kingdom
Royal Sussex County Hospital
Eastern Road
Brighton
BN2 5BE
United Kingdom
Maidstone Hospital
Hermitage Lane
Maidstone
ME16 9QQ
United Kingdom
Kent and Canterbury Hospital
Ethelbert Road
Canterbury
CT1 3NG
United Kingdom
Kingston Hospital
Galsworthy Road
Kingston-upon-Thames
KT2 7QB
United Kingdom
Liverpool Women's Hospital
Crown Street
Liverpool
L8 7SS
United Kingdom
Clatterbridge Cancer Centre - Aintree
Lower Lane
Fazakerley
Liverpool
L9 7AL
United Kingdom
Norfolk and Norwich University Hospital
Colney Lane
Norwich
NR4 7UY
United Kingdom
Royal Surrey County Hospital
Egerton Road
Guildford
GU2 7XX
United Kingdom
Croydon University Hospital
530 London Road
Croydon
CR7 7YE
United Kingdom
Epsom Hospital
Dorking Road
Epsom
KT18 7EG
United Kingdom
St Helier Hospital
Wrythe Lane
Sutton
Carshalton
SM5 1AA
United Kingdom
Gloucestershire NHS Foundation Trust
Trust Headquarters
Alexandra House
Cheltenham General Hospital
Sandford Road
Cheltenham
GL53 7AN
United Kingdom
Gateshead Health NHS Foundation Trust
Elisabeth Queen Hospital
Sheriff Hill
Gateshead
NE9 6SX
United Kingdom
Cambridge University Hospitals NHS Foundation Trust
Addenbrooke's Hospital
Cambridge Biomedical Campus
Hills Road
Cambridge
CB2 0QQ
United Kingdom
London North West University Healthcare NHS Trust
Watford Road
Harrow
HA1 3UJ
United Kingdom

Sponsor information

Imperial College London (UK)
University/education

Joint Research Compliance Office
Room 510C, 5th Floor, Lab Block
Charing Cross Hospital
Fulham Palace Road
London
W6 8RF
England
United Kingdom

ROR logo "ROR" https://ror.org/041kmwe10

Funders

Funder type

Government

National Institute for Health Research
Government organisation / National government
Alternative name(s)
National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
Location
United Kingdom

Results and Publications

Intention to publish date01/05/2024
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planPlanned publication in a high-impact peer reviewed journal.
IPD sharing planThe datasets generated during and/or analysed during the current study are/will be available upon request from Prof. Andrea Rockall.

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Protocol file version v4.3 04/09/2020 02/12/2020 No No
HRA research summary 28/06/2023 No No

Additional files

ISRCTN51246892_v4.3_04Sep2020.pdf
uploaded 02/12/2020

Editorial Notes

20/02/2024: The following changes were made to the study record:
1. The total final enrolment number was changed from 645 to 648.
2. The overall study end date was changed from 30/09/2022 to 08/02/2023.
3. The intention to publish date was changed from 31/05/2023 to 01/05/2024.
09/08/2022: The overall end date was changed from 31/08/2022 to 30/09/2022.
03/02/2022: The following changes have been made:
1. The overall trial end date has been changed from 01/09/2021 to 31/08/2022 and the plain English summary has been updated to reflect this change.
2. The total final enrolment number has been added.
3. The intention to publish date has been changed from 01/05/2022 to 31/05/2023.
15/02/2021: The following changes have been made:
1. The overall trial end date has been changed from 28/02/2021 to 01/09/2021.
2. The intention to publish date has been changed from 30/11/2021 to 01/05/2022.
02/12/2020: Uploaded protocol (not peer reviewed) Version 4.3, 4 September 2020.
09/09/2020: The public contact has been changed.
07/09/2020: The recruitment end date has been changed from 30/09/2020 to 30/12/2020.
22/06/2020: The recruitment end date has been changed from 30/05/2020 to 30/09/2020.
14/01/2020: The following changes have been made:
1. The recruitment end date has been changed from 31/12/2019 to 30/05/2020.
2. The overall trial end date has been changed from 30/10/2020 to 28/02/2021.
3. The intention to publish date has been changed from 31/12/2020 to 30/11/2021.
20/11/2018: The following changes were made to the trial record:
1. Publication and dissemination plan and IPD sharing statement added.
2. Trial participating centres added (Gloucestershire NHS Foundation Trust, Gateshead Health NHS Foundation Trust, Cambridge University Hospitals NHS Foundation Trust, London North West University Healthcare NHS Trust).
3. Contact changed from Dr Aakta Patel to Anna Nikopoulou.
08/02/2018: The recruitment start date was changed from 14/03/2016 to 01/03/2016.
18/12/2017: The following changes were made:
1. Dr Aakta Patel replaced Miss Hannah Reaney as the study contact.
2. The overall trial start date was changed from 01/07/2015 to 01/12/2015.
3. The recruitment start date was changed from 01/02/2016 to 14/03/2016.
4. The recruitment end date was changed from 29/11/2019 to 31/12/2019.
5. The overall trial end date was changed from 31/08/2020 to 30/10/2020.
6. Northern Gynaecological Oncology Centre, Royal Preston Hospital, Pan Birmingham Cancer Centre, Saint Bartholomew's Hospital, Royal Cornwall Hospital, St James's University Hospital, Queen’s Medical Centre, The Ipswich Hospital and Queen Elizabeth the Queen Mother Hospital were removed as trial participating centres.
7. Kent and Canterbury Hospital, Kingston Hospital, Liverpool Women's Hospital, Clatterbridge Cancer Centre – Aintree, Norfolk and Norwich University Hospital, Royal Surrey County Hospital, Croydon University Hospital, Epsom Hospital and St Helier Hospital were added as trial participating centres.
09/08/2016: Cancer Help UK lay summary link added.
01/04/2016: Ethics approval information added.