Implementation of Whole-Body MRI (MY-RADS) within the OPTIMUM/MUKnine multi-centre clinical trial for patients with myeloma

Abstract

Background Whole-body (WB) MRI, which includes diffusion-weighted imaging (DWI) and T1-w Dixon, permits sensitive detection of marrow disease in addition to qualitative and quantitative measurements of disease and response to treatment of bone marrow. We report on the first study to embed standardised WB-MRI within a prospective, multi-centre myeloma clinical trial (IMAGIMM trial, sub-study of OPTIMUM/MUKnine) to explore the use of WB-MRI to detect minimal residual disease after treatment. Methods The standardised MY-RADS WB-MRI protocol was set up on a local 1.5 T scanner. An imaging manual describing the MR protocol, quality assurance/control procedures and data transfer was produced and provided to sites. For non-identical scanners (different vendor or magnet strength), site visits from our physics team were organised to support protocol optimisation. The site qualification process included review of phantom and volunteer data acquired at each site and a teleconference to brief the multidisciplinary team. Image quality of initial patients at each site was assessed. Results WB-MRI was successfully set up at 12 UK sites involving 3 vendor systems and two field strengths. Four main protocols (1.5 T Siemens, 3 T Siemens, 1.5 T Philips and 3 T GE scanners) were generated. Scanner limitations (hardware and software) and scanning time constraint required protocol modifications for 4 sites. Nevertheless, shared methodology and imaging protocols enabled other centres to obtain images suitable for qualitative and quantitative analysis. Conclusions Standardised WB-MRI protocols can be implemented and supported in prospective multi-centre clinical trials. Trial registration NCT 03188172 clinicaltrials.gov; registration date 15th June 2017 https://clinicaltrials.gov/ct2/show/study/NCT03188172

Real-world advantage and challenge of post-autologous stem cell transplantation MRD negativity in high-risk patients with double-hit multiple myeloma

“…While the introduction of CD38 Ab-based quadruplet regimens is likely to enhance the initial response rates in DH patients, maintaining sustained MRD negativity requires tailored post-ASCT intensified treatment. Analyses from the MASTER, FORTE, and UK OPTIMUM/MUKnine trials advocate risk-adapted post-ASCT consolidation for this patient cohort [ 8 , 29 , 30 ]. Moreover, adding carfilzomib to lenalidomide maintenance extends PFS beyond lenalidomide alone, across all cytogenetic risk groups in the FORTE [ 7 ], further supporting intensified maintenance for DH patients.…”

Image quality in whole-body MRI using the MY-RADS protocol in a prospective multi-centre multiple myeloma study

“…This image quality assessment has shown for the first time that it is possible to successfully deliver a multi-centre WB-MRI study using the MY-RADS protocol, even from sites with a range of hardware and prior WB-MRI experience. This underlines the importance of the site qualification process [ 19 ], which established acquisition protocols that were optimised to local conditions and ensured that all sites were capable of delivering high quality imaging prior to patient enrolment. Quantitative metrics of image quality have been shown to have good repeatability and correlation with radiological assessment and could be developed further to provide a pipeline for automated QC of WB-MRI data in multi-centre studies.…”

“…The sites underwent a site qualification process [ 19 ] to establish a MY-RADS-compliant imaging protocol consisting of axial DWI, axial T 1 w Dixon imaging and sagittal T 1 w and T 2 w spine imaging on a local scanner. Hardware and software limitations and scan time constraints required some protocol modifications between sites (full details are included in a prior publication [ 19 ]). Volunteer or exemplar patient data from each site were reviewed by the lead site to confirm that sufficient data quality was achievable prior to patient enrolment.…”

Prediction of Bone Marrow Biopsy Results From MRI in Multiple Myeloma Patients Using Deep Learning and Radiomics

“…Given that, in vivo, the reproducibility of radiomics features at other scanners is worse than their repeatability, 26 this heterogeneity probably limited the accuracy of the predictions, which is also in line with our finding that the performance of the predictive models declined in the external data sets. Therefore, further standardization of MRI scanners and protocols, as currently ongoing, 58 in general standardization of radiomics pipelines, 29 and application of advanced data harmonization methods, [59][60][61] should be pursued to improve the performance of our approach in the future. A further limitation is that when biopsy was performed before MRI, this had caused postbioptic BM changes and thereby influenced the images.…”