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

NHS Trust

Status: Completed

Conditions: Smouldering Myeloma; Monoclonal Gammopathy of Undetermined Significance (MGUS); Myeloma

Treatments: Other: Diffusion Weighted Magnetic Resonance Imaging (DWMRI); Other: Bloods and urine; Other: DXA scan

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT03951220

12548

Details and patient eligibility

About

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.

Full 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.

Enrollment: 67 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

67 participants in 3 patient groups

Group 1- Myeloma

Description:

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.

Treatment:

Other: DXA scan

Other: Bloods and urine

Other: Diffusion Weighted Magnetic Resonance Imaging (DWMRI)

Group 2- MGUS

Description:

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.

Treatment:

Other: DXA scan

Other: Bloods and urine

Other: Diffusion Weighted Magnetic Resonance Imaging (DWMRI)

Group 3- Healthy Volunteers

Description:

Participants will have the experimental combined MR imaging.

Treatment:

Other: Diffusion Weighted Magnetic Resonance Imaging (DWMRI)