Status:

COMPLETED

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

Lead Sponsor:

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Conditions:

Multiple Myeloma

Eligibility:

All Genders

18-80 years

Phase:

NA

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 d...

Detailed Description

PROTOCOL SYNOPSIS - Study Type Monocentric prospective clinical trial Study Object Comparison of Whole Body Diffusion Weighted Magnetic Resonance Imaging (DW-MRI) with skeletal X-Ray and MRI of the s...

Eligibility Criteria

Inclusion

  • .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

  • 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

Key Trial Info

Start Date :

July 1 2008

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

July 1 2012

Estimated Enrollment :

50 Patients enrolled

Trial Details

Trial ID

NCT01829412

Start Date

July 1 2008

End Date

July 1 2012

Last Update

April 11 2013

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