Clinical Trials Directory

Trials / Completed

CompletedNCT01284829

Performance of 18F-Fluorodeoxyglucose Positron Emission Tomography (FDG-PET) in the Diagnosis of Indeterminate Adrenal Tumors on Conventional Imaging: A French Prospective Multicentric Study

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
87 (actual)
Sponsor
Assistance Publique Hopitaux De Marseille · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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 description

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).

Conditions

Interventions

TypeNameDescription
OTHERFDG-PET scan

Timeline

Start date
2011-02-04
Primary completion
2013-10-10
Completion
2023-04-05
First posted
2011-01-27
Last updated
2023-04-06

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT01284829. Inclusion in this directory is not an endorsement.