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

Information source: Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Adrenal Tumors

Intervention: FDG-PET scan (Other)

Phase: N/A

Status: Recruiting

Sponsored by: Assistance Publique Hopitaux De Marseille

Official(s) and/or principal investigator(s):
DAVID TAEB, Principal Investigator, Affiliation: Assistance Publique hôpitaux de Marseille

Overall contact:
DAVID TAEB, Phone: 0491385904, Email: david.taeb@ap-hm.fr

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.

Clinical Details

Official title: 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 design: Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Primary outcome: diagnostic accuracy of FDG-PETparticularly the SUVmax tumor/liver ratio, in the diagnosis of indeterminate adrenal tumors on conventional imaging.

Secondary outcome:

assess the diagnostic accuracy of the tumorSUVmax, 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).

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).

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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.

Locations and Contacts

DAVID TAEB, Phone: 0491385904, Email: david.taeb@ap-hm.fr

Assistance Publique Hopitaux de Marseille, Marseille 13354, France; Recruiting
david taeb, Phone: 0491385904, Email: david.taeb@ap-hm.fr
david taeb, Principal Investigator
Additional Information

Starting date: November 2010
Last updated: August 28, 2014

Page last updated: August 20, 2015

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