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

Public Assistance-Hospitals of Marseille (AP-HM)

Status

Completed

Conditions

Adrenal Tumors

Treatments

Other: FDG-PET scan

Study type

Interventional

Funder types

Other

Identifiers

NCT01284829

2010-A00705-34

2010 08 (Other Identifier)

Details and patient eligibility

About

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.

Full 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).

Enrollment

87 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Adult ≥ 18 yrs, male or female;
Indeterminate adrenal tumor (6.3.1.). The CT must include the calculation of SD and contrast washout and should have been performed within the 30 days before the inclusion visit (visit 0) ;
Patient insured with public health care system ;
Patient who accept to participate to the study and to sign the consent document form.

Exclusion criteria