Clinical trial NCT03951220: The Development and Pilot Testing of a New MR Imaging Protocol to Quantify Myeloma Disease Burden and Bone Loss
Official title: The Development and Pilot Testing of a New Magnetic Resonance (MR) Imaging Protocol to Quantify Both Myeloma Disease Burden and Associated Bone Loss
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Myeloma
Monoclonal Gammopathy of Undetermined Significance (MGUS)
Smouldering Myeloma
Lead sponsor: Oxford University Hospitals NHS Trust
Sponsor class: OTHER
Collaborators: name: Amgen
First posted: 2019-05-15
Enrollment: 67
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants in Groups 1 \& 2 will be recruited via the Haematology Outpatients clinic in Churchill Hospital.

Group 3 participants will be recruited from the community

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.

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.

Primary outcomes:
measure: 1. DW-MRI: ADC change
timeFrame: At baseline and six months
measure: 2. Total spinal 'hole' volume
timeFrame: At baseline and six months
measure: 3. Total spine 'collapse' volume
timeFrame: At baseline and six months
measure: 4. FSA: trabecular wall thickness
timeFrame: At baseline and six months
Secondary outcomes:
measure: Detect longitudinal changes in tumour load with therapy
timeFrame: At 6 months
measure: Assess participants Quality of Life (EQ-5D) throughout the study
timeFrame: At baseline and six months
measure: Assess participants experience of the novel MR imaging scan
timeFrame: At baseline and six months
Other outcomes:
Locations:
city: Oxford
country: United Kingdom
facility: Churchill Hospital
state: Oxfordshire
Study officials:
affiliation: University of Oxford Hospitals NHS Foundation Trust
name: Karthik Ramasamy
role: PRINCIPAL_INVESTIGATOR
References: