Ovarian cancer Cancer Ovarian cancer
Conditions
Interventions
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 sit
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 up
Sponsors
Imperial College London (UK)
Eligibility
Sex/Gender
Female
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
England, Scotland, United Kingdom
Contacts
Public ContactAmanda Bigault
Outcome results
None listed