Overview

This trial is active, not recruiting.

Condition adrenal tumors
Treatment fdg-pet scan
Sponsor Assistance Publique Hopitaux De Marseille
Start date February 2011
End date November 2015
Trial size 165 participants
Trial identifier NCT01284829, 2010 08, 2010-A00705-34

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose diagnostic
Arm
(Experimental)
adrenal tumors
fdg-pet scan

Primary Outcomes

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

Secondary Outcomes

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

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

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
Principal investigator DAVID TAEB
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).
Trial information was received from ClinicalTrials.gov and was last updated in September 2015.
Information provided to ClinicalTrials.gov by Assistance Publique Hopitaux De Marseille.