MR in ovarian cancer
| 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
Plain English summary of protocol
Contact information
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 |
|---|---|
| mroc@imperial.ac.uk |
Scientific
1st Floor, ICTEM building
Hammersmith Hospital Campus
Du Cane Road
London
W12 0NN
United Kingdom
Study information
| Study design | Multi-centre diagnostic accuracy trial |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cross sectional study |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | The impact of multiparametric MRI on the staging and management of patients with suspected or confirmed ovarian cancer |
| Study acronym | MROC |
| Study objectives | 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(s) | Committee: London – City Road and Hampstead, 03/12/2015, REC Ref: 15/LO/1904 |
| Health condition(s) or problem(s) studied | 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 and blood samples, which would be obtained during surgery at participating hospitals who routinely collect fresh-frozen tissue. |
| Intervention type | Other |
| Primary outcome measure | 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 study start date | 01/12/2015 |
| Completion date | 08/02/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target number of participants | 645 |
| Total final enrolment | 648 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/03/2016 |
| Date of final enrolment | 30/12/2020 |
Locations
Countries of recruitment
- England
- Scotland
- United Kingdom
Study participating centres
London
W12 0NN
United Kingdom
London
SW3 6JJ
United Kingdom
London
NW1 2BU
United Kingdom
Glasgow
G12 0YN
United Kingdom
Brighton
BN2 5BE
United Kingdom
Maidstone
ME16 9QQ
United Kingdom
Canterbury
CT1 3NG
United Kingdom
Kingston-upon-Thames
KT2 7QB
United Kingdom
Liverpool
L8 7SS
United Kingdom
Fazakerley
Liverpool
L9 7AL
United Kingdom
Norwich
NR4 7UY
United Kingdom
Guildford
GU2 7XX
United Kingdom
Croydon
CR7 7YE
United Kingdom
Epsom
KT18 7EG
United Kingdom
Sutton
Carshalton
SM5 1AA
United Kingdom
Alexandra House
Cheltenham General Hospital
Sandford Road
Cheltenham
GL53 7AN
United Kingdom
Sheriff Hill
Gateshead
NE9 6SX
United Kingdom
Cambridge Biomedical Campus
Hills Road
Cambridge
CB2 0QQ
United Kingdom
Harrow
HA1 3UJ
United Kingdom
Sponsor information
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" |
https://ror.org/041kmwe10 |
|---|
Funders
Funder type
Government
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 date | 01/05/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer reviewed journal. |
| IPD sharing plan | The 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.
