MRI in Multiple Myeloma: Analysis of the Axial Skeleton Versus Whole Body. What is the Required Analysis?

Terminated

• Conditions: Myeloma
• Interventions: Diagnostic Test: MRI

• Registration Number: NCT03618212
• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes

Brief Summary

The investigators wish to determine which anatomic regions need to be explored in order to correctly diagnose myeloma: whether axial skeletal MRI alone is sufficient or whether it is necessary to perform a total skeletal MRI.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-08-01
• Study First Submitted QC: 2018-08-01
• Study First Posted: 2018-08-07
• Study Start: 2018-12-21
• Primary Completion: 2020-03-31
• Study Completion: 2020-03-31
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-03
• Last Update Posted: 2021-08-09

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

• The patient must have given their free and informed consent and signed the consent form
• The patient must be a member or beneficiary of a health insurance plan
• The patient is at least 18 years old
• Patient has been diagnosed with multiple myeloma (> 10% medullary plasma cells + monoclonal protein) or symptomatic myeloma (myeloma + CRAB symptoms (hypercalcemia, renal failure, anemia, bone lesions), or indolent myeloma (myeloma with symptomatic criteria).

Exclusion Criteria

• The subject refuses to sign the consent
• It is impossible to give the subject informed information
• The patient is under safeguard of justice or state guardianship
• The patient is pregnant or breast feeding
• The patient has an absolute contra-indication for MRI (pace-maker, claustrophobic patient, metal heart valve)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Myeloma patients	MRI	-

Primary Outcome Measures

Name	Time	Method
Identification of focal lesions ≥ 5mm by axial skeletal MRI of spine and pelvis versus whole-body MRI using diffusion sequences	Day 0	Fatty tissue replacement by tumoral tissue observed by hyposignal T1 and hypersignal T2 FS or short-TI Inversion Recovery ≥ 5mm

Secondary Outcome Measures

Name	Time	Method
Number of "punched out" lesions ≥ 5mm identified by whole-body MRI with diffusion sequences versus skeletal X-ray	Day 0
Agreement between identification of normal lesions ≥ 5mm by axial skeletal MRI of spine and pelvis versus whole-body MRI using diffusion sequences	Day 0
Agreement between identification of diffuse lesions ≥ 5mm by axial skeletal MRI of spine and pelvis versus whole-body MRI using diffusion sequences	Day 0
Agreement between identification of mixed lesions ≥ 5mm by axial skeletal MRI of spine and pelvis versus whole-body MRI using diffusion sequences	Day 0
Agreement between identification of salt and pepper lesions ≥ 5mm by axial skeletal MRI of spine and pelvis versus whole-body MRI using diffusion sequences	Day 0
Link between type of infiltration and spinal cord karyotype	Day 0	Yes/no presence of anomaly, and if yes, type of karyotype anomaly
Inter-observer reproducibility for the first 20 patients for the detection of focal lesions ≥ 5mm by axial skeletal MRI of spine and pelvis	Day 0

Trial Locations

Locations (2)

CHU Montpellier; 🇫🇷 Montpellier, France

CHU Nimes; 🇫🇷 Nîmes, France