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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by Universitaire Ziekenhuizen Leuven
Sponsor:
Information provided by (Responsible Party):
Steven Pans, Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier:
NCT01780766
First received: January 26, 2013
Last updated: January 28, 2013
Last verified: January 2013
  Purpose

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
Multiple Myeloma

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Universitaire Ziekenhuizen Leuven:

Primary Outcome Measures:
  • Validation [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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:
  • Therapy assessment [ Time Frame: 4 years ] [ Designated as safety issue: No ]

    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:
  • outcome [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    correlation between early treatment response and outcome of the patient by measuring apparent diffusion coefficient


Estimated Enrollment: 100
Study Start Date: September 2008
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Indolent myeloma patient
Symptomatic Myeloma patient

  Eligibility

Ages Eligible for Study:   25 Years and older
Genders Eligible for Study:   Both
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.)
  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: 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
  More Information

Publications:
Responsible Party: Steven Pans, Medical Doctor Radiologist, Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT01780766     History of Changes
Other Study ID Numbers: FIMM, S51079
Study First Received: January 26, 2013
Last Updated: January 28, 2013
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products

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

Additional relevant MeSH terms:
Body Weight
Multiple Myeloma
Neoplasms, Plasma Cell
Signs and Symptoms
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 July 10, 2014