Whole Body Diffusion Weighted Magnetic Resonance Imaging (DW-MRI) in Multiple Myeloma (MMY-MRI-08)
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ClinicalTrials.gov Identifier: NCT01829412 |
Recruitment Status :
Completed
First Posted : April 11, 2013
Last Update Posted : April 11, 2013
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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 or disease | Intervention/treatment | Phase |
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Multiple Myeloma | Other: DW-MRI | Not Applicable |

Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 50 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (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 |
Study Start Date : | July 2008 |
Actual Primary Completion Date : | July 2012 |
Actual Study Completion Date : | July 2012 |

Arm | Intervention/treatment |
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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:
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Other: DW-MRI
MRI imaging with diffusion weighted sequences of the whole body
Other Name: Whole Body Diffusion Weighted Magnetic Resonance Imaging |
- 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 ]
- 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 ]
- 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 ]
- 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 ]
- 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 ]Exploratory objective

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Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01829412
Principal Investigator: | Paolo Corradini, Professor | Fondazione IRCCS Istituto Nazionale dei Tumori , Via Venezian, 1- 20133 Milano, Italy |
Responsible Party: | Paolo Corradini, Professor, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano |
ClinicalTrials.gov Identifier: | NCT01829412 |
Other Study ID Numbers: |
MMY-MRI-08 |
First Posted: | April 11, 2013 Key Record Dates |
Last Update Posted: | April 11, 2013 |
Last Verified: | April 2013 |
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 |