Clinical Trial: Performance of 18F-Fluorodeoxyglucose Positron Emission Tomography (FDG-PET) in the Diagnosis of Indeterminate Adrenal Tumors on Conventional Imaging: A French Prospective Multicentric Study
Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional
Official Title: Performance of 18F-Fluorodeoxyglucose Positron Emission Tomography (FDG-PET) in the Diagnosis of Indeterminate Adrenal Tumors on Conventional Imaging: A French Prospective
Brief Summary:
This is a prospective study which aims to validate a new diagnostic approach in the tissue characterization of adrenal tumors indeterminate on conventional imaging. For this purpose, it is not necessary to have a control group since the diagnostic accuracy in a well defined subset of patients.
Visit 0 : Enrollment, eligibility. Visit 1 : FDG-PET. Visit 2 : Postoperative visit. Visit 3 : 6 months post-PET. Visit 4 : 12 months post-PET.
Detailed Summary:
Primary objective The primary objective is to assess the diagnostic accuracy of FDG-PET, particularly the SUVmax tumor/liver ratio, in the diagnosis of indeterminate adrenal tumors on conventional imaging.
Secondary objectives
- To assess the diagnostic accuracy of the tumor SUVmax, and SUVmax of the tumor/mean SUV of the liver.
- To evaluate the relationship between SUVmax tumor/liver ratio and Weiss score.
- To evaluate the impact of the use of FDG-PET on the treatment options.
- To evaluate the economic impact of FDG-PET in the management of indeterminate adrenal tumors (ancillary study).
Sponsor: Assistance Publique Hopitaux De Marseille
Current Primary Outcome: diagnostic accuracy of FDG-PETparticularly the SUVmax tumor/liver ratio, in the diagnosis of indeterminate adrenal tumors on conventional imaging. [ Time Frame: 3 YEARS ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- assess the diagnostic accuracy of the tumorSUVmax, and SUVmax of the tumor/mean SUV of the liver. [ Time Frame: 3 YEARS ]
- To evaluate the relationship between SUVmax tumor/liver ratio and Weiss score [ Time Frame: 3 years ]
- To evaluate the impact of the use of FDG-PET on the treatment options [ Time Frame: 3 years ]
- To evaluate the economic impact of FDG-PET in the management of indeterminate adrenal tumors (ancillary study). [ Time Frame: 3 years ]
Original Secondary Outcome: Same as current
Information By: Assistance Publique Hopitaux De Marseille
Dates:
Date Received: January 13, 2011
Date Started: February 2011
Date Completion: November 2015
Last Updated: September 29, 2015
Last Verified: September 2015