The Development and Pilot Testing of a New MR Imaging Protocol to Quantify Myeloma Disease Burden and Bone Loss
- Conditions
- Smouldering MyelomaMonoclonal Gammopathy of Undetermined Significance (MGUS)Myeloma
- Interventions
- Other: Diffusion Weighted Magnetic Resonance Imaging (DWMRI)Other: DXA scanOther: Bloods and urine
- Registration Number
- NCT03951220
- Lead Sponsor
- Oxford University Hospitals NHS Trust
- Brief 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.
- Detailed Description
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.
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), the investigators 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. 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.
The investigators hypothesize that this imaging tool will be superior to the combined current standard-of-care investigations in the quantification of tumour burden and bone loss. There are currently no tools available for quantifying structural changes to bone and overall bone loss in myeloma.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 67
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Group 1- Myeloma DXA scan 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. Group 2- MGUS Bloods and urine 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. Group 3- Healthy Volunteers Diffusion Weighted Magnetic Resonance Imaging (DWMRI) Participants will have the experimental combined MR imaging. Group 1- Myeloma Diffusion Weighted Magnetic Resonance Imaging (DWMRI) 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. Group 2- MGUS DXA scan 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. Group 1- Myeloma Bloods and urine 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. Group 2- MGUS Diffusion Weighted Magnetic Resonance Imaging (DWMRI) 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.
- Primary Outcome Measures
Name Time Method 3. Total spine 'collapse' volume At baseline and six months This will be calculated using the DW-MRI scans at both baseline and follow up
1. DW-MRI: ADC change At baseline and six months This will be calculated using the DW-MRI scans at both baseline and follow up
2. Total spinal 'hole' volume At baseline and six months This will be calculated using the DW-MRI scans at both baseline and follow up 3. Total spine 'collapse' volume 4. FSA: trabecular wall thickness (Rafferty et al, 2016)
4. FSA: trabecular wall thickness At baseline and six months This will be calculated using the DW-MRI scans at both baseline and follow up
- Secondary Outcome Measures
Name Time Method Detect longitudinal changes in tumour load with therapy At 6 months All imaging will be repeated at 6 months. The scans will be analysed to see the difference in number of tumour sites before and after therapy (at baseline and at six months). Scans at both time points will be compared to see the difference in ADC, total spinal 'hole' volume, total spine 'collapse' volume and the trabecular wall thickness.
Assess participants Quality of Life (EQ-5D) throughout the study At baseline and six months Assess participants Quality of Life (EQ-5D) throughout the study life using data from the EQ-5D-5L questionnaire.
The EQ-5D assess the mobility, self-care, usual activities, pain/discomfort, anxiety and depression via 3 options ranging from 'no problems' to 'unable to do/extreme pain/anxious'. The second part of the EQ-5D assess health on a scale where 100 is the best and 0 is the worst.Assess participants experience of the novel MR imaging scan At baseline and six months Analyse participants experience of the novel MR imaging using data from MRI/DXA scanning questionnaire.
This questionnaire assesses the experience of the novel imaging scan, whether any pain/discomfort was experienced. These answers are recorded on a 5 point likert scale where the lower number represents a better outcome.
Trial Locations
- Locations (1)
Churchill Hospital
🇬🇧Oxford, Oxfordshire, United Kingdom