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NCT00200668 Clinical Trial

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

Multiple Myeloma Clinical Trial

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00200668
Other study ID # BRD/04/6-H
Secondary ID
Status Terminated
Phase N/A
First received September 12, 2005
Last updated June 5, 2008
Start date March 2005
Est. completion date December 2006

Study information
Verified date June 2008
Source Nantes University Hospital
Contact n/a
Is FDA regulated No
Health authority France: Ministry of Health
Study type Interventional

Clinical Trial Summary

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

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)

Recruitment information / eligibility
Status Terminated
Enrollment 0
Est. completion date December 2006
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility 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

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

Intervention

Drug:
• FDG = fluorodeoxyglucose

Locations
Country Name City State
France Nantes University Hospital Nantes

Sponsors (1)
Lead Sponsor Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

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