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

Sponsor
Oxford University Hospitals NHS Trust
Study ID
NCT03951220
Status
Completed

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Accepted

Interventions

  • Diffusion Weighted Magnetic Resonance Imaging (DWMRI) — OTHER
    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.
  • DXA scan — OTHER
    Used to assess bone density
  • Bloods and urine — OTHER
    Samples will be taken to assess bone biomarkers

Study Details

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.

Key Dates

Start date
Mar 29, 2018
Status verified
Jul 2025
Primary completion
Dec 30, 2020
Completion
Dec 30, 2020

Study Design

Enrollment
67 participants (actual)

Arms

  • Arm: Group 1- Myeloma
    Participants will be recruited at the point of either diagnosis or relapse. Any standard investigations that the clinician deems necessary will be carried out. Following recruitment, participants will undergo the first study appointment, the experimental combined MR imaging protocol, the DXA imaging scan and the bone biomarker blood and urine tests. This will be repeated at 6 months.
  • Arm: Group 2- MGUS
    Participants will be recruited at the point of either diagnosis or relapse. Any standard investigations that the clinician deems necessary will be carried out. Following recruitment, participants will undergo the first study appointment, the experimental combined MR imaging protocol, the DXA imaging scan and the bone biomarker blood and urine tests. This will be repeated at 6 months.
  • Arm: Group 3- Healthy Volunteers
    Participants will have the experimental combined MR imaging.

Primary Outcome Measure

Primary Outcome 1: Quantifying Tumour Burden [Correlations With Apparent Diffusion Coefficient (ADC) Measurements] [ Time Frame: At baseline ]

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