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Whole Body MRI Imaging in Multiple Myeloma at 3 Tesla MRI : Added Value of Diffusion Weighted Imaging

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ClinicalTrials.gov Identifier: NCT01780766
Recruitment Status : Unknown
Verified January 2013 by Steven Pans, Universitaire Ziekenhuizen Leuven.
Recruitment status was:  Recruiting
First Posted : January 31, 2013
Last Update Posted : January 31, 2013
Sponsor:
Information provided by (Responsible Party):
Steven Pans, Universitaire Ziekenhuizen Leuven

Brief Summary:

Whole body MRI with diffusion weighted imaging is a useful imaging tool

  • staging and diagnosis
  • therapy monitoring All patients will be scanned before and during treatment. The findings on diffusion weighted imaging will be correlated to the golden standard (computer tomography and MRI (T1 and STIR)).

Condition or disease
Multiple Myeloma

Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Whole Body MRI Imaging in Multiple Myeloma at 3 Tesla MRI: What is the Added Value of Diffusion Weighted Imaging in Diagnosis and Follow-up
Study Start Date : September 2008
Estimated Primary Completion Date : March 2013
Estimated Study Completion Date : September 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort
Indolent myeloma patient
Symptomatic Myeloma patient



Primary Outcome Measures :
  1. Validation [ Time Frame: 2 years ]
    Validation of whole body MRI diffusion-weighted imaging in multiple myeloma at 3 Tesla MRI: correlation of the new MRI imaging technique (diffusion weighted imaging)to standard validated imaging technique (Computer Tomography and Magnetic Resonance Imaging)


Secondary Outcome Measures :
  1. Therapy assessment [ Time Frame: 4 years ]

    Whole body MRI with Diffusion weighted imaging is useful for treatment monitoring in multiple myeloma patients during and after therapy.

    Measurement of apparent diffusion coefficient (ADC) and comparison of ADC before, during and after therapy. Correlation of ADC with clinical findings and standard MRI findings.



Other Outcome Measures:
  1. outcome [ Time Frame: 5 years ]
    correlation between early treatment response and outcome of the patient by measuring apparent diffusion coefficient



Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with clinical and laboratory findings, highly suggestive for multiple myeloma. All patients underwent bone marrow biopsy.
Criteria

Inclusion Criteria:

  • Patients with clinical and laboratory findings, highly suggestive for multiple myeloma.

Exclusion Criteria:

  • All patients who are not allowed to be scanned on MRI (Pacemaker, implants ed.)

Information from the National Library of Medicine

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): NCT01780766


Contacts
Contact: Steven Pans, MD 3216340505 steven.pans@uzleuven.be

Locations
Belgium
University Hospitals Leuven Recruiting
Leuven, Belgium
Contact: Steven Pans, MD    3216340505    steven.pans@uzleuven.be   
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
Investigators
Principal Investigator: Steven Pans, MD Universitaire Ziekenhuizen Leuven

Publications:
Responsible Party: Steven Pans, Medical Doctor Radiologist, Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT01780766     History of Changes
Other Study ID Numbers: FIMM
S51079 ( Other Identifier: Clinical Trial Centre UZ Leuven )
First Posted: January 31, 2013    Key Record Dates
Last Update Posted: January 31, 2013
Last Verified: January 2013

Keywords provided by Steven Pans, Universitaire Ziekenhuizen Leuven:
Whole body MRI
Multiple myeloma
Diffusion Weighted MRI
Whole body scan

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Body Weight
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
Signs and Symptoms