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

This study has been terminated.

Sponsored by:	Nantes University Hospital
Information provided by:	Nantes University Hospital
ClinicalTrials.gov Identifier:	NCT00200668

Purpose

Comparison between FDG-PET and MRI for the assessment of response to intensive chemotherapy in multiple myeloma patients.

Condition	Intervention
Multiple Myeloma	Drug: FDG = fluorodeoxyglucose

Genetics Home Reference related topics: aceruloplasminemia hemophilia

MedlinePlus related topics: Multiple Myeloma

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment

Further study details as provided by Nantes University Hospital:

Enrollment:	0
Study Start Date:	March 2005
Study Completion Date:	December 2006

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)

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00200668

Locations

France
Nantes University Hospital
Nantes, France, 44093

Sponsors and Collaborators

Nantes University Hospital

Investigators

Principal Investigator:

Olivier Couturier, MD

Nantes University Hospital

More Information

Study ID Numbers:	BRD/04/6-H
Study First Received:	September 12, 2005
Last Updated:	June 5, 2008
ClinicalTrials.gov Identifier:	NCT00200668
Health Authority:	France: Ministry of Health

Study placed in the following topic categories:

Immunoproliferative Disorders
Hemorrhagic Disorders
Multiple myeloma
Hematologic Diseases
Blood Protein Disorders
Blood Coagulation Disorders

Vascular Diseases
Paraproteinemias
Lymphoproliferative Disorders
Hemostatic Disorders
Neoplasms, Plasma Cell
Multiple Myeloma

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Histologic Type
Immune System Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009