Whole Body Diffusion Weighted Magnetic Resonance Imaging (DW-MRI) in Multiple Myeloma (MMY-MRI-08)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Paolo Corradini, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
ClinicalTrials.gov Identifier:
NCT01829412
First received: April 9, 2013
Last updated: NA
Last verified: April 2013
History: No changes posted
  Purpose

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).


Condition Intervention
Multiple Myeloma
Other: DW-MRI

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Comparison of Whole Body Diffusion Weighted Magnetic Resonance Imaging (DW-MRI) With Skeletal X-Ray and MRI of the Spine for the Assessment of Bone Disease in Multiple Myeloma

Resource links provided by NLM:


Further study details as provided by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano:

Primary Outcome Measures:
  • 1) To assess whether DW-MRI can detect a higher number of bone lesions than standard X-Ray and MRI of the spine [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 1) To assess whether the change in the number of lesions detected with DW-MRI at follow up correlate with disease response to therapy [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • 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) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • 3) To assess whether DW-MRI detects a higher number of bone lesions than Whole Body Magnetic Resonance Imaging (WB-MRI) [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • 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 [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Exploratory objective


Enrollment: 50
Study Start Date: July 2008
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: DW- MRI

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
MRI imaging with diffusion weighted sequences of the whole body
Other Name: Whole Body Diffusion Weighted Magnetic Resonance Imaging

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:•

.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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01829412

Sponsors and Collaborators
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Investigators
Principal Investigator: Paolo Corradini, Professor Fondazione IRCCS Istituto Nazionale dei Tumori , Via Venezian, 1- 20133 Milano, Italy
  More Information

No publications provided

Responsible Party: Paolo Corradini, Professor, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
ClinicalTrials.gov Identifier: NCT01829412     History of Changes
Other Study ID Numbers: MMY-MRI-08
Study First Received: April 9, 2013
Last Updated: April 9, 2013
Health Authority: Italy: National Monitoring Centre for Clinical Trials - Ministry of Health

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on September 18, 2014