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

NCT ID: NCT03618212

Last Updated: 2021-08-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

12 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-12-21

Study Completion Date

2020-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Myeloma

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Myeloma patients

MRI

Intervention Type DIAGNOSTIC_TEST

Skeletal MRI and pelvic and spinal MRI

Interventions

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MRI

Skeletal MRI and pelvic and spinal MRI

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Nīmes

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ahmed Larbi, MD

Role: PRINCIPAL_INVESTIGATOR

CHU Nimes

Locations

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CHU Montpellier

Montpellier, , France

Site Status

CHU Nimes

Nîmes, , France

Site Status

Countries

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France

Other Identifiers

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AOIGCSMERRIL/2016/AL-01

Identifier Type: -

Identifier Source: org_study_id

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