Back to resultsComparison Between FDG-PET and MRI for the Assessment of Response to Intensive Chemotherapy in Multiple Myeloma Patients.
Primary Purpose
Multiple Myeloma
Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
FDG = fluorodeoxyglucose
Sponsored by
About this trial
This is an interventional diagnostic trial for Multiple Myeloma
Eligibility 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
Sites / Locations
- Nantes University Hospital
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00200668
First Posted
September 12, 2005
Last Updated
June 5, 2008
Sponsor
Nantes University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00200668
Brief Title
Comparison Between FDG-PET and MRI for the Assessment of Response to Intensive Chemotherapy in Multiple Myeloma Patients.
Study Type
Interventional
2. Study Status
Record Verification Date
June 2008
Overall Recruitment Status
Terminated
Study Start Date
March 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Nantes University Hospital
4. Oversight
5. Study Description
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
FDG = fluorodeoxyglucose
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Olivier Couturier, MD
Organizational Affiliation
Nantes University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nantes University Hospital
City
Nantes
ZIP/Postal Code
44093
Country
France
12. IPD Sharing Statement
Learn more about this trial
Comparison Between FDG-PET and MRI for the Assessment of Response to Intensive Chemotherapy in Multiple Myeloma Patients.
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