Development and validation of an algorithm to detect and measure bone disease on whole-body MRI in patients with multiple myeloma
Multiple myeloma
Current methodology as of 15/06/2026: WISER-M is a multi-centre, multi-cohort retrospective study involving collection and analyses of routinely acquired whole-body MRI scans and clinical diagnostic and clinical outcome data in patients with myeloma to develop and validate an algorithm for automated detection and measurement of bone disease on whole-body MRI, including: A. Single-centre retrospective study (Training/Internal Validation cohort): Retrospective collection and analysis of whole-body MRI scans and limited diagnostic clinical, laboratory and pathology data from a single UK site for training of a whole-body MRI algorithm for detecting and measuring bone disease in patients with active focal disease associated with myeloma – Royal Marsden Hospital (n=200) B. Multi-centre retrospective study (External Validation cohort): Retrospective collection and analysis of whole-body MRI scans from up to 6 UK sites excluding Royal Marsden Hospital for validation of the whole-body MRI algorithm for detecting and measuring bone disease in patients with newly diagnosed myeloma (n=60) C. Clinical Usability Sub-study: clinical review of up to 20 case studies from the Training Cohort to evaluate clinical usability of the software. This will provide preliminary evidence to inform design of future real-world testing of a validated myeloma-specific algorithm. For newly diagnosed cases included in (A) and (B) the following clinical, laboratory and pathology data routinely acquired during the patient’s diagnostic and treatment pathway, and available within electronic patient records, will be collected: 1. Date of confirmed diagnosis of myeloma 2. Laboratory markers of disease burden (blood and urinary tumour markers, bone marrow biopsy) 3. Molecular subtype and other molecular characteristics if available 4. Patient management recommendations including treatment and follow-up schedule following confirmed diagnosis and prior to start of treatment pathway 5. Clinical outcome d
Patients with a confirmed diagnosis of multiple myeloma who underwent a whole-body MRI scan as standard of care during their diagnostic (Training/Internal Validation & External Validation Cohorts) and/or treatment (Training/Internal Validation Cohort only) pathway, within the preceding 8 years, fulfilling all of the following: 1. WBMRI scan acquisition protocol included axial-diffusion-weighted MRI with at least 2 b-values 2. WBMRI scan acquisition protocol included axial Dixon T1-weighted MRI 3. WBMRI scan showed at least two radiographically active focal lesions defined as high signal on diffusion-weighted imaging, low ADC values (500-10000s/mm²) and low relative fact fraction (< 20%)
Inadequate whole-body MRI image quality