Condition category
Cancer
Date applied
17/11/2015
Date assigned
30/11/2015
Last edited
09/08/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Contact information

Type

Public

Primary contact

Miss Hannah Reaney

ORCID ID

http://orcid.org/0000-0003-1225-1758

Contact details

Cancer Research UK Imperial Centre: Clinical Trials Section
Department of Surgery and Cancer
Imperial College London
3rd Floor Radiotherapy Building
Hammersmith Hospital Campus
Du Cane Road
London
W12 0NN
United Kingdom
+44 (0)20 7594 2180
h.reaney@imperial.ac.uk

Type

Scientific

Additional contact

Prof Andrea Rockall

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

C/33/2014

Study information

Scientific title

The impact of multiparametric MRI on the staging and management of patients with suspected or confirmed ovarian cancer

Acronym

MROC

Study hypothesis

The 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

Committee: London – City Road and Hampstead, 03/12/2015, REC Ref: 15/LO/1904

Study design

Multi-centre diagnostic accuracy trial

Primary study design

Observational

Secondary study design

Cross sectional 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

Ovarian cancer

Intervention

645 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 samples, which would be obtained during surgery at hospitals who routinely collect fresh-frozen tissue.

Intervention type

Other

Phase

Drug names

Primary outcome measures

Comparison 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 measures

1. 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 trial start date

01/07/2015

Overall trial end date

31/08/2020

Reason abandoned

Eligibility

Participant inclusion criteria

1. 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 type

Patient

Age group

Adult

Gender

Female

Target number of participants

645

Participant exclusion criteria

1. 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 date

01/02/2016

Recruitment end date

29/11/2019

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Hammersmith Hospital
Du Cane Road
London
W12 0NN
United Kingdom

Trial participating centre

The Royal Marsden Hospital
Fulham Road
London
SW3 6JJ
United Kingdom

Trial participating centre

University College Hospital
235 Euston Road
London
NW1 2BU
United Kingdom

Trial participating centre

Northern Gynaecological Oncology Centre
Queen Elizabeth Hospital
Gateshead
NE9 6SX
United Kingdom

Trial participating centre

Royal Preston Hospital
Sharoe Green Lane Fulwood
Preston
PR2 9HT
United Kingdom

Trial participating centre

Pan Birmingham Cancer Centre
City Hospital Trust Dudley Road
Birmingham
B18 7QH
United Kingdom

Trial participating centre

Beatson West of Scotland Cancer Centre
1053 Great Western Road
Glasgow
G12 0YN
United Kingdom

Trial participating centre

Saint Bartholomew's Hospital
West Smithfield
London
EC1A 7BE
United Kingdom

Trial participating centre

Royal Cornwall Hospital
2 Penventinnie Lane Treliske
Truro
TR1 3LJ
United Kingdom

Trial participating centre

St James's University Hospital
Beckett Street
Leeds
LS9 7TF
United Kingdom

Trial participating centre

Queen’s Medical Centre
Derby Road
Nottingham
NG7 2UH
United Kingdom

Trial participating centre

Royal Sussex County Hospital
Eastern Road
Brighton
BN2 5BE
United Kingdom

Trial participating centre

Queen Elizabeth the Queen Mother Hospital
St Peter's Road
Margate
CT9 4AN
United Kingdom

Trial participating centre

Maidstone Hospital
Hermitage Lane
Maidstone
ME16 9QQ
United Kingdom

Trial participating centre

The Ipswich Hospital
Heath Road
Ipswich
IP4 5PD
United Kingdom

Sponsor information

Organisation

Imperial College London (UK)

Sponsor details

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

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

09/08/2016: Cancer Help UK lay summary link added. 01/04/2016: Ethics approval information added.