Clinical trial · Interventional
Whole Body Diffusion Weighted Magnetic Resonance Imaging (DW-MRI) in Multiple Myeloma
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| DW-MRI | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- DW- MRI
- description
- 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. .
- interventionNames
- Other: DW-MRI
Primary outcomes (1)
- measure
- 1) To assess whether DW-MRI can detect a higher number of bone lesions than standard X-Ray and MRI of the spine
- timeFrame
- 12 months
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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
References
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