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

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01284829

Enrollment

Registered

2011-01-27

Start date

2011-02-04

Completion date

2023-04-05

Last updated

2023-04-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adrenal Tumors

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).

Interventions

OTHERFDG-PET scan

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
assess the diagnostic accuracy of the tumorSUVmax, and SUVmax of the tumor/mean SUV of the liver.	3 YEARS
To evaluate the relationship between SUVmax tumor/liver ratio and Weiss score	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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026