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The Development and Pilot Testing of a New MR Imaging Protocol to Quantify Myeloma Disease Burden and Bone Loss

NCT03951220 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 67

Last updated 2025-08-19

Study results available
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Summary

In the proposed study, the investigators will aim to develop and pilot a Magnetic Resonance (MR) imaging protocol and assess its ability to achieve the following: quantification of tumour burden and bone loss, detecting longitudinal changes in tumour load with therapy and detecting longitudinal changes in microarchitecture with therapy. The investigators also aim to investigate whether bone loss is better, worse or the same with different imaging techniques. This will be investigated by correlating the DXA imaging data with Diffusion-Weighted Magnetic Resonance Imaging (DWMRI) to see if it is possible to achieve quantifiable data of bone density.

Conditions

  • Myeloma
  • Monoclonal Gammopathy of Undetermined Significance (MGUS)
  • Smouldering Myeloma

Interventions

OTHER

Diffusion Weighted Magnetic Resonance Imaging (DWMRI)

Using the expertise of the Oxford Centre For Clinical Magnetic Resonance Research (OCMR) for imaging protocol development, and the new Fine Structural Analysis (FSA, Osteotronix Ltd, formerly Acuitas Medical) bone density quantification MRI method (Rafferty et al 2016), we will test a single protocol which combines three emerging experimental imaging sequences into a simple, non-invasive whole body imaging protocol to quantify disease burden and bone disease. To our knowledge, this has never been done before; if shown to be feasible, such a method would have two important applications: to precisely guide commissioned therapies in the clinic, so improving patient management; and as an exciting, novel research tool for the longitudinal combined assessment of tumour burden and cancer-induced bone disease in response to therapy.

OTHER

DXA scan

Used to assess bone density

OTHER

Bloods and urine

Samples will be taken to assess bone biomarkers

Sponsors & Collaborators

  • Amgen

    collaborator INDUSTRY

  • Oxford University Hospitals NHS Trust

    lead OTHER

Principal Investigators

  • Karthik Ramasamy · University of Oxford Hospitals NHS Foundation Trust

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-03-29
Primary Completion
2020-12-30
Completion
2020-12-30

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03951220 on ClinicalTrials.gov