N/A N=67

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

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

Bottom Line

View on ClinicalTrials.gov: NCT03951220 ↗

Enrolled (actual)

Serious AEs

—

Results posted

Aug 2025

Primary outcome: Primary: Primary Outcome 1: Quantifying Tumour Burden [Correlations With Apparent Diffusion Coefficient (ADC) Measurements] — -0.66; NA; -0.28; 0.48 Pearson's correlation coefficient

Study Design & Population

Study type: Observational
Phase: N/A
Interventions: Diffusion Weighted Magnetic Resonance Imaging (DWMRI) (Other); DXA scan (Other); Bloods and urine (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Oxford University Hospitals NHS Trust
Primary completion: Dec 2020

Outcome Measures

Outcome	Result	p-value
PRIMARY Primary Outcome 1: Quantifying Tumour Burden [Correlations With Apparent Diffusion Coefficient (ADC) Measurements]	-0.66; NA; -0.28; 0.48	—
PRIMARY Primary Outcome 1: Quantifying Tumour Burden [Correlations With Myeloma Response Assessment and Diagnosis System (MY-RADS) Pattern of Disease]	13.1; 11.7; 5.4; 17.2	0.7343
PRIMARY Primary Outcome 1: Quantifying Tumour Burden (Correlations With Bone Turnover Markers)	0.31; 0.01; -0.18; 0.39; 0.23; -0.02	0.0445 sig
PRIMARY Primary Outcome 2: Quantifying Bone Loss - Inter-Group Differences in Baseline Serum P1NP (Procollagen Type 1 N-terminal Propeptide)	38.6; 39.5; 39.6; 39.3	0.0079 sig
PRIMARY Primary Outcome 2: Quantifying Bone Loss - Inter-Group Differences in Baseline Serum CTX-1 (Collagen Cross-Linked C-Telopeptide Type I)	0.38; 0.40; 0.39; 0.39	—
PRIMARY Primary Outcome 2: Quantifying Bone Loss - Inter-Group Differences in Baseline Serum ALP (Alkaline Phosphatase)	73.8; 73.3; 72.2; 74.0	—
PRIMARY Primary Outcome 2: Quantifying Bone Loss - Inter-Group Differences in Baseline Serum DKK1 (Dickkopf WNT Signaling Pathway Inhibitor 1)	3963.6; 4018.9; 3759.2; 3924.5	—
PRIMARY Primary Outcome 2: Quantifying Bone Loss - Inter-Group Differences in Baseline Serum Sclerostin	168.5; 165.5; 166.9; 164.9	—
PRIMARY Primary Outcome 2: Quantifying Bone Loss - Inter-Group Differences in Baseline Serum Ratio of RANKL (Receptor Activator of Nuclear Factor Kappa-Β Ligand) and OPG (Osteoprotegerin)	0.0170; 0.0176; 0.0397; 0.0386	—
PRIMARY Primary Outcome 2: Quantifying Bone Loss (Inter-Biomarker Correlations)	0.70; 0.37; 0.12; 0.22; -0.10; 0.25	—
PRIMARY Primary Outcome 2: Quantifying Bone Loss [Correlations Between Bone Turnover Markers, DXA (Dual-energy X-ray Absorptiometry) and ADC (Apparent Diffusion Coefficient)]	0.02; 0.00; 0.16; 0.25; 0.54; -0.02	—
PRIMARY Primary Outcome 1+2: Quantifying Tumour Burden (Total Spinal 'Hole' Volume)	—	—
PRIMARY Primary Outcome 1+2: Quantifying Tumour Burden (Total Spinal 'Collapse' Volume)	—	—
PRIMARY Primary Outcome 1+2: Quantifying Tumour Burden [Osteotronix Fine Structural Analysis (FSA), Trabecular Wall Thickness]	—	—
SECONDARY Secondary Outcome 1: Detect Longitudinal Changes in Tumour Load With Therapy [MY-RADS RAC (Myeloma Response Assessment and Diagnosis System Response Assessment Classification) vs IMWG (International Myeloma Working Group) Response Group Classification]	0; 0; 0; 2; 3; 0	0.015 sig
SECONDARY Secondary Outcome 1: Detect Longitudinal Changes in Tumour Load With Therapy [MY-RADS RAC (Myeloma Response Assessment and Diagnosis System Response Assessment Classification) vs % Change in ADC (Apparent Diffusion Coefficient)]	0.45; 1.40; 1.29; 0.57; 1.61	—
SECONDARY Secondary Outcome 1: Detect Longitudinal Changes in Tumour Load With Therapy [% Change in ADC (Apparent Diffusion Coefficient) vs IMWG (International Myeloma Working Group) Response Group Classification]	1.6; 0.90; 0.99; 1.9	—
SECONDARY Secondary Outcome 2: Detect Longitudinal Changes in Bone Microarchitecture With Therapy (% Change in Bone Turnover Markers)	0.94; 0.89; 0.85; 0.63; 1.22; 1.09	0.007 sig
SECONDARY Secondary Outcome 2: Detect Longitudinal Changes in Bone Microarchitecture With Therapy (Correlations Between % Change in Bone Turnover Markers)	0.41; 0.36; 0.12; 0.32; 0.41; 0.08	—
SECONDARY Secondary Outcome 2: Detect Longitudinal Changes in Bone Microarchitecture With Therapy [Correlations Between % Change in Bone Turnover Markers With % Change in Bone Mineral Density (BMD) or Apparent Diffusion Coefficient (ADC)]	-0.39; 0.31; -0.50; -0.32; -0.32; -0.14	—
SECONDARY Secondary Objective 3: Assess Participants' Quality of Life Throughout the Study	1.29; 1.23; 1.00; 1.11; 1.08; 1.00	—
SECONDARY Secondary Outcome 4: Assess Participants' Experience of Novel Magnetic Resonance (MR) and Dual-energy X-ray Absorptiometry (DXA) Scans	2.10; 2.10; 2.13; 0.30; 0.31; 0.33	—

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.

Eligibility Criteria

Inclusion Criteria (All Groups):

Participant is able to and willing to give informed consent for participation in the study.
Male or Female, aged 18 years or above.

Inclusion Criteria (Groups 1 and 2):

Newly diagnosed myeloma or newly relapsed myeloma eligible for next therapy.
Smouldering myeloma or intermediate or high risk MGUS.
Patients attending Oxford NHS Haematology-Oncology centre.
Diagnoses of MGUS, Smouldering Myeloma and MM made in accordance with the clinical diagnostic criteria set forth by IMWG (International Myeloma Working Group).

Exclusion Criteria (All Groups):

Those who are unable or unwilling to give informed consent.
Women who may be pregnant, breast feeding or women of child-bearing potential who are unwilling or unable to take sufficient precautionary measures will be excluded due to DXA imaging.

Exclusion Criteria (Groups 1 and 2):

Signs of Spinal Cord Compression.
Patients with documented metastatic lesions from another type of malignancy.
Known contraindication for a MRI scan, including unacceptable pain on lying flat for 1 hour.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03951220). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.