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

Myeloma Clinical Trial

— MYMO  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03618212
• Other study ID #: AOIGCSMERRIL/2016/AL-01
• Status: Terminated
• Start date: December 21, 2018
• Est. completion date: March 31, 2020

Study information

• Verified date: August 2021
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 12
• Est. completion date: March 31, 2020
• Est. primary completion date: March 31, 2020
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Multiple Myeloma
• Myeloma
• Neoplasms, Plasma Cell

Intervention

Diagnostic Test:
• MRI
Skeletal MRI and pelvic and spinal MRI

Locations

Country	Name	City	State
France	CHU Montpellier	Montpellier
France	CHU Nimes	Nîmes

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Identification of focal lesions = 5mm by axial skeletal MRI of spine and pelvis versus whole-body MRI using diffusion sequences	Fatty tissue replacement by tumoral tissue observed by hyposignal T1 and hypersignal T2 FS or short-TI Inversion Recovery = 5mm	Day 0
Secondary	Number of "punched out" lesions = 5mm identified by whole-body MRI with diffusion sequences versus skeletal X-ray		Day 0
Secondary	Agreement between identification of normal lesions = 5mm by axial skeletal MRI of spine and pelvis versus whole-body MRI using diffusion sequences		Day 0
Secondary	Agreement between identification of diffuse lesions = 5mm by axial skeletal MRI of spine and pelvis versus whole-body MRI using diffusion sequences		Day 0
Secondary	Agreement between identification of mixed lesions = 5mm by axial skeletal MRI of spine and pelvis versus whole-body MRI using diffusion sequences		Day 0
Secondary	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
Secondary	Link between type of infiltration and spinal cord karyotype	Yes/no presence of anomaly, and if yes, type of karyotype anomaly	Day 0
Secondary	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