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

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ClinicalTrials.gov Identifier: NCT00200668
Recruitment Status : Terminated
First Posted : September 20, 2005
Last Update Posted : June 9, 2008
Sponsor:
Information provided by:
Nantes University Hospital

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

Condition or disease Intervention/treatment Phase
Multiple Myeloma Drug: FDG = fluorodeoxyglucose Not Applicable

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 : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Study Start Date : March 2005
Actual Study Completion Date : December 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma
U.S. FDA Resources





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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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

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): NCT00200668


Locations
France
Nantes University Hospital
Nantes, France, 44093
Sponsors and Collaborators
Nantes University Hospital
Investigators
Principal Investigator: Olivier Couturier, MD Nantes University Hospital

ClinicalTrials.gov Identifier: NCT00200668     History of Changes
Other Study ID Numbers: BRD/04/6-H
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: June 9, 2008
Last Verified: June 2008

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
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
Fluorodeoxyglucose F18
Radiopharmaceuticals
Molecular Mechanisms of Pharmacological Action