Comparison Between FDG-PET and MRI for the Assessment of Response to Intensive Chemotherapy in Multiple Myeloma Patients.

Tracking Information
First Submitted Date ICMJE	September 12, 2005
First Posted Date ICMJE	September 20, 2005
Last Update Posted Date	June 9, 2008
Study Start Date ICMJE	March 2005
Primary Completion Date	Not Provided
Current Primary Outcome Measures ICMJE	Not Provided
Original Primary Outcome Measures ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT00200668 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE	Not Provided
Original Secondary Outcome Measures ICMJE	Not Provided
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Comparison Between FDG-PET and MRI for the Assessment of Response to Intensive Chemotherapy in Multiple Myeloma Patients.
Official Title ICMJE	Not Provided
Brief Summary	Comparison between FDG-PET and MRI for the assessment of response to intensive chemotherapy in multiple myeloma patients.
Detailed Description	First whole body FDG-PET scan and MRI before the start of the treatment. Second whole body FDG-PET scan and MRI after the end of the treatment. On a basis of patient, comparison between PET and MRI will be done tumoral site by site. Sensitivity, Specificity will be estimated for both techniques. In case of discrepancy, another imaging method or biopsy (if easy to perform) will be serve as standard of reference. Kappa coefficients and Mc Nemar test will be performed to compare the two methods. FDG = fluorodeoxyglucose FLUCIS® (Schering-CisBio® international)
Study Type ICMJE	Interventional
Study Phase	Not Applicable
Study Design ICMJE	Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Diagnostic
Condition ICMJE	Multiple Myeloma
Intervention ICMJE	Drug: FDG = fluorodeoxyglucose
Study Arms	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Terminated
Actual Enrollment ICMJE; (submitted: June 5, 2008)	0
Original Enrollment ICMJE; (submitted: September 12, 2005)	80
Actual Study Completion Date	December 2006
Primary Completion Date	Not Provided
Eligibility Criteria ICMJE	Inclusion Criteria: Patients from 18 to 65 years old.; De novo histologically proven multiple myeloma. Exclusion Criteria: No history of another cancer or of HIV; No history of renal failure
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years to 65 Years (Adult)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	France
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT00200668
Other Study ID Numbers ICMJE	BRD/04/6-H
Has Data Monitoring Committee	Not Provided
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Not Provided
Study Sponsor ICMJE	Nantes University Hospital
Collaborators ICMJE	Not Provided
Investigators ICMJE	Principal Investigator: Olivier Couturier, MD Nantes University Hospital
PRS Account	Nantes University Hospital
Verification Date	June 2008
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP