Clinical trial NCT03618212: MRI in Multiple Myeloma: Analysis of the Axial Skeleton Versus Whole Body. What is the Required Analysis?
Official title: MRI in Multiple Myeloma: Analysis of the Axial Skeleton Versus Whole Body. What is the Required Analysis?
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Myeloma
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2018-08-07
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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

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.


Eligibility 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)

Primary outcomes:
measure: Identification of focal lesions ≥ 5mm by axial skeletal MRI of spine and pelvis versus whole-body MRI using diffusion sequences
timeFrame: Day 0
Secondary outcomes:
measure: Number of "punched out" lesions ≥ 5mm identified by whole-body MRI with diffusion sequences versus skeletal X-ray
timeFrame: Day 0
measure: Agreement between identification of normal lesions ≥ 5mm by axial skeletal MRI of spine and pelvis versus whole-body MRI using diffusion sequences
timeFrame: Day 0
measure: Agreement between identification of diffuse lesions ≥ 5mm by axial skeletal MRI of spine and pelvis versus whole-body MRI using diffusion sequences
timeFrame: Day 0
measure: Agreement between identification of mixed lesions ≥ 5mm by axial skeletal MRI of spine and pelvis versus whole-body MRI using diffusion sequences
timeFrame: Day 0
measure: Agreement between identification of salt and pepper lesions ≥ 5mm by axial skeletal MRI of spine and pelvis versus whole-body MRI using diffusion sequences
timeFrame: Day 0
measure: Link between type of infiltration and spinal cord karyotype
timeFrame: Day 0
measure: Inter-observer reproducibility for the first 20 patients for the detection of focal lesions ≥ 5mm by axial skeletal MRI of spine and pelvis
timeFrame: Day 0
Other outcomes:
Locations:
city: Montpellier
country: France
facility: CHU Montpellier
city: Nîmes
country: France
facility: CHU Nimes
Study officials:
affiliation: CHU Nimes
name: Ahmed Larbi, MD
role: PRINCIPAL_INVESTIGATOR
References: