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

NCT03618212 | Terminated

• 1 other identifier: AOIGCSMERRIL/2016/AL-01
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 2

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.

Conditions

Myeloma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• 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

Study Arms (1)

Myeloma patients

Diagnostic Test: MRI

Interventions

MRI DIAGNOSTIC_TEST

Skeletal MRI and pelvic and spinal MRI

Myeloma patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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).

You may not qualify if:

• 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)

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (2)

CHU Montpellier

Montpellier, 34090, France

Location

CHU Nimes

Nîmes, 30029, France

Location

MeSH Terms

Conditions

Neoplasms, Plasma Cell

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms

Study Officials

• Ahmed Larbi, MD

  CHU Nimes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2018
• First Posted: August 7, 2018
• Study Start: December 21, 2018
• Primary Completion: March 31, 2020
• Study Completion: March 31, 2020
• Last Updated: August 9, 2021

Record last verified: 2021-08

Locations

FR (2)