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

This study has been terminated.

Sponsor:

Information provided by:

Nantes University Hospital

ClinicalTrials.gov Identifier:

NCT00200668

First received: September 12, 2005

Last updated: June 5, 2008

Last verified: June 2008

History of Changes

Tracking Information

First Received Date ^ICMJE

September 12, 2005

Last Updated Date

June 5, 2008

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 Provided

Study Design ^ICMJE

Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: 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

Enrollment ^ICMJE

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

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

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