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

Multiple Myeloma Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01780766
• Other study ID #: FIMM
• Secondary ID: S51079
• Status: Recruiting
• Phase: N/A
• First received: January 26, 2013
• Last updated: January 28, 2013
• Start date: September 2008
• Est. completion date: September 2014

Study information

• Verified date: January 2013
• Source: Universitaire Ziekenhuizen Leuven
• Contact: Steven Pans, MD
• Phone: 3216340505
• Email: steven.pans[@]uzleuven.be
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicinal Products and Health Products
• Study type: Observational

Clinical Trial 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)).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: September 2014
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 25 Years and older

Eligibility

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.)

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Locations

Country	Name	City	State
Belgium	University Hospitals Leuven	Leuven

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen Leuven

Country where clinical trial is conducted

Belgium, 

References & Publications (1)

Bannas P, Hentschel HB, Bley TA, Treszl A, Eulenburg C, Derlin T, Yamamura J, Adam G, Stübig T, Kröger N, Weber C. Diagnostic performance of whole-body MRI for the detection of persistent or relapsing disease in multiple myeloma after stem cell transplantation. Eur Radiol. 2012 Sep;22(9):2007-12. doi: 10.1007/s00330-012-2445-y. Epub 2012 Apr 29. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	outcome	correlation between early treatment response and outcome of the patient by measuring apparent diffusion coefficient	5 years	No
Primary	Validation	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)	2 years	No
Secondary	Therapy assessment	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.	4 years	No