WISER-M
Research type
Research Study
Full title
Development and validation of an algorithm to detect and measure bone disease on whole-body MRI in patients with multiple myeloma
IRAS ID
315705
Contact name
Christina Messiou
Contact email
Sponsor organisation
The Institute of Cancer Research
Duration of Study in the UK
1 years, 3 months, 30 days
Research summary
In multiple myeloma, NICE recommends whole-body MRI for diagnostic staging. However, a survey showed that only 10% of NHS sites use whole-body MRI, despite it being more accurate and being more cost effective. There are a number of reasons for this including a lack of expertise to perform this type of scan and interpret the images, and a lack of software for whole-body MRI analysis. Where used, whole-body MRI scans are reviewed visually by radiologists, who will then produce a text-based report. This is limited because there can be variation in image interpretation by different radiologists, review time can be long and qualitative descriptions (such as small vs. large volume) can be imprecise. Through previous NIHR funding, together with a commercial partner, a CE-labelled software for identification and quantitation of bone disease has been developed for use in patients with metastatic prostate cancer. This software may also have a role in detecting and measuring bone disease in patients with suspected myeloma, requiring development and validation of a myeloma-specific software algorithm. The WISER-M study involves the retrospective collection of whole-body MRI scans and limited patient data, previously acquired as part of routine care and available via electronic patient records. It has two main objectives:
1. to develop and internally validate a myeloma-specific algorithm with optimal diagnostic performance to detect and measure bone disease on whole-body MRI in patients with active focal disease associated with multiple myeloma via a single-centre retrospective study (Training/Internal Validation cohort, n=100 cases)
2. to externally validate the diagnostic performance of the algorithm as measured by its per-lesion sensitivity to detect focal lesions in newly diagnosed myeloma cases via a multi-centre retrospective study (External Validation cohort, n=60 cases).
WISER-M also includes a sub-study to evaluate clinical usability to provide preliminary evidence to inform future trials testing a validated myeloma-specific algorithm.REC name
West of Scotland REC 5
REC reference
24/WS/0076
Date of REC Opinion
24 Jun 2024
REC opinion
Favourable Opinion