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

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

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03618212
Acronym
MYMO
Enrollment
12
Registered
2018-08-07
Start date
2018-12-21
Completion date
2020-03-31
Last updated
2021-08-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myeloma

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.

Interventions

DIAGNOSTIC_TESTMRI

Skeletal MRI and pelvic and spinal MRI

Sponsors

Centre Hospitalier Universitaire de Nīmes
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

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)

Design outcomes

Primary

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

Secondary

MeasureTime frameDescription
Agreement between identification of normal lesions ≥ 5mm by axial skeletal MRI of spine and pelvis versus whole-body MRI using diffusion sequencesDay 0
Agreement between identification of diffuse lesions ≥ 5mm by axial skeletal MRI of spine and pelvis versus whole-body MRI using diffusion sequencesDay 0
Agreement between identification of mixed lesions ≥ 5mm by axial skeletal MRI of spine and pelvis versus whole-body MRI using diffusion sequencesDay 0
Number of punched out lesions ≥ 5mm identified by whole-body MRI with diffusion sequences versus skeletal X-rayDay 0
Link between type of infiltration and spinal cord karyotypeDay 0Yes/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 pelvisDay 0
Agreement between identification of salt and pepper lesions ≥ 5mm by axial skeletal MRI of spine and pelvis versus whole-body MRI using diffusion sequencesDay 0

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026