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 Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

87 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-04

Study Completion Date

2023-04-05

Brief Summary

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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.

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Detailed Description

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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

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Adrenal Tumors

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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adrenal tumors

Group Type EXPERIMENTAL

FDG-PET scan

Intervention Type OTHER

Interventions

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FDG-PET scan

Intervention Type OTHER

Eligibility Criteria

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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.