Whole Body Diffusion Weighted Magnetic Resonance Imaging (DW-MRI) in Multiple Myeloma

NCT01829412 | Completed

• 1 other identifier: MMY-MRI-08
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

Bone disease in multiple myeloma (MM) is routinely assessed by skeletal X-ray (XR) and magnetic resonance of the spine (S-MRI). Diffusion-weighted MRI (DW-MRI) is a functional MRI that detects water diffusion through cells. This prospective phase II study compared whole-body DW-MRI with XR and S-MRI for the assessment of MM bone lesions. METHODS. Thirty-six consecutive symptomatic patients at diagnosis or at relapse performed XR, S-MRI, whole-body MRI, and whole-body DW-MRI before treatment, after treatment, and 6 months after treatment. A substudy evaluated 12 asymptomatic patients at diagnosis, after 6 and 12 months. Radiology exams were independently read by 3 experienced radiologists, and the techniques were compared by the count of segments with focal lesions (FL) (\>=5mm).

Conditions

Multiple Myeloma

Outcome Measures

Primary Outcomes (1)

• 1) To assess whether DW-MRI can detect a higher number of bone lesions than standard X-Ray and MRI of the spine

  12 months

Secondary Outcomes (3)

• 1) To assess whether the change in the number of lesions detected with DW-MRI at follow up correlate with disease response to therapy

  12 months

• 2) To assess whether the change in the number of lesions detected with DW-MRI at follow up correlate with time to re-treatment (TTR)

  12 months

• 3) To assess whether DW-MRI detects a higher number of bone lesions than Whole Body Magnetic Resonance Imaging (WB-MRI)

  12 months

Other Outcomes (1)

• 1) To assess whether DW-MRI detects more bone lesions than standard staging procedures in Stage I asymptomatic MM patients at diagnosis not requiring treatment

  12 months

Study Arms (1)

DW- MRI

EXPERIMENTAL

The patients will perform the DW-MRI, WB-MRI and MRI of the spine in the same session with the following timing: 1. Patients at first-line treatment for MM: 1. Within 15 days before the start of the treatment 2. Within one month after the end of the first-line treatment 3. Six (6) months after the end of the first-line treatment 2. Patients at relapse after disease response (CR or PR) lasting at least 6 months 1. At relapse 2. Within 15 days after the end of the treatment of relapse 3. Six (6) months after the end of the treatment of relapse Each DW-MRI, WB-MRI, MRI of the spine and skeletal X-Ray will be independently read and interpreted by two radiologists with proven experience in MM. .

Other: DW-MRI

Interventions

DW-MRI OTHER

MRI imaging with diffusion weighted sequences of the whole body

Also known as: Whole Body Diffusion Weighted Magnetic Resonance Imaging

DW- MRI

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years , \< 80 years
• Stage I-III (Durie-Salmon) symptomatic MM at the start of first-line treatment or at relapse after disease response (CR or PR) lasting at least 6 months
• Stage I (Durie-Salmon) asymptomatic MM at diagnosis not requiring treatment (substudy for assessment of exploratory objectives)
• Written informed consent

You may not qualify if:

• Pregnancy or lactation
• Active secondary malignancy
• Type I hypersensitivity or anaphylactic reactions to Gadolinum contrast agent
• Mental disorders including claustrophobia (ICD 10, F40.2)
• Electronically, magnetically and mechanically activated implants
• Ferromagnetic or electrically operated active devices like automatic cardioverter defibrillators
• Cardiac pacemakers
• Metallic splinters in the eye
• Ferromagnetic haemostatic clips in the central nervous system (CNS) or in the body
• Cochlear implants or stapedial implants
• Insulin pumps and nerve stimulators
• Prosthetic hearth valves

Sponsors & Collaborators

• Fondazione IRCCS Istituto Nazionale dei Tumori, Milano: lead

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Paolo Corradini, Professor

  Fondazione IRCCS Istituto Nazionale dei Tumori , Via Venezian, 1- 20133 Milano, Italy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 9, 2013
• First Posted: April 11, 2013
• Study Start: July 1, 2008
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: April 11, 2013

Record last verified: 2013-04