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

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ClinicalTrials.gov Identifier: NCT03618212
Recruitment Status : Terminated (Departure of the project leader)
First Posted : August 7, 2018
Last Update Posted : August 9, 2021
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes

Study Description
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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.

Condition or disease Intervention/treatment
Myeloma Diagnostic Test: MRI

Study Design
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Study Type : Observational
Actual Enrollment : 12 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: MRI in Multiple Myeloma: Analysis of the Axial Skeleton Versus Whole Body. What is the Required Analysis?
Actual Study Start Date : December 21, 2018
Actual Primary Completion Date : March 31, 2020
Actual Study Completion Date : March 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

Groups and Cohorts
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Group/Cohort Intervention/treatment
Myeloma patients Diagnostic Test: MRI
Skeletal MRI and pelvic and spinal MRI


Outcome Measures
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Primary Outcome Measures :
  1. Identification of focal lesions ≥ 5mm by axial skeletal MRI of spine and pelvis versus whole-body MRI using diffusion sequences [ Time Frame: 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 :
  1. Number of "punched out" lesions ≥ 5mm identified by whole-body MRI with diffusion sequences versus skeletal X-ray [ Time Frame: Day 0 ]
  2. Agreement between identification of normal lesions ≥ 5mm by axial skeletal MRI of spine and pelvis versus whole-body MRI using diffusion sequences [ Time Frame: Day 0 ]
  3. Agreement between identification of diffuse lesions ≥ 5mm by axial skeletal MRI of spine and pelvis versus whole-body MRI using diffusion sequences [ Time Frame: Day 0 ]
  4. Agreement between identification of mixed lesions ≥ 5mm by axial skeletal MRI of spine and pelvis versus whole-body MRI using diffusion sequences [ Time Frame: Day 0 ]
  5. Agreement between identification of salt and pepper lesions ≥ 5mm by axial skeletal MRI of spine and pelvis versus whole-body MRI using diffusion sequences [ Time Frame: Day 0 ]
  6. Link between type of infiltration and spinal cord karyotype [ Time Frame: Day 0 ]
    Yes/no presence of anomaly, and if yes, type of karyotype anomaly

  7. Inter-observer reproducibility for the first 20 patients for the detection of focal lesions ≥ 5mm by axial skeletal MRI of spine and pelvis [ Time Frame: Day 0 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Patients with myeloma as diagnosed according to the International Myeloma Working Group criteria recruited in the service of clinical hematology in either the CHUs of Nîmes or Montpellier
Criteria

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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03618212


Locations
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France
CHU Montpellier
Montpellier, France, 34090
CHU Nimes
Nîmes, France, 30029
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nīmes
Investigators
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Principal Investigator: Ahmed Larbi, MD CHU Nimes
More Information
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Responsible Party: Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier: NCT03618212    
Other Study ID Numbers: AOIGCSMERRIL/2016/AL-01
First Posted: August 7, 2018    Key Record Dates
Last Update Posted: August 9, 2021
Last Verified: August 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
 Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases