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

Not Applicable

Completed

• Conditions: Adrenal Tumors
• Interventions: Other: FDG-PET scan

• Registration Number: NCT01284829
• Lead Sponsor: Assistance Publique Hopitaux De Marseille

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 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).

Study Timeline

• Study First Submitted: 2011-01-13
• Study First Submitted QC: 2011-01-26
• Study First Posted: 2011-01-27
• Study Start: 2011-02-04
• Primary Completion: 2013-10-10
• Status Verified: 2023-04
• Study Completion: 2023-04-05
• Last Update Submitted: 2023-04-05
• Last Update Posted: 2023-04-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 87

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

• Technical inability to perform FDG-PET.
• Patient's death before final diagnosis.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
adrenal tumors	FDG-PET scan	adrenal tumors

Primary Outcome Measures

Name	Time	Method
diagnostic accuracy of FDG-PETparticularly the SUVmax tumor/liver ratio, in the diagnosis of indeterminate adrenal tumors on conventional imaging.	3 YEARS

Secondary Outcome Measures

Name	Time	Method
To evaluate the relationship between SUVmax tumor/liver ratio and Weiss score	3 years
assess the diagnostic accuracy of the tumorSUVmax, and SUVmax of the tumor/mean SUV of the liver.	3 YEARS
To evaluate the impact of the use of FDG-PET on the treatment options	3 years
To evaluate the economic impact of FDG-PET in the management of indeterminate adrenal tumors (ancillary study).	3 years

Trial Locations

Locations (1)

Assistance Publique Hopitaux de Marseille; 🇫🇷 Marseille, France