Clinical trial NCT01284829: Performance of 18F-Fluorodeoxyglucose Positron Emission Tomography (FDG-PET) in the Diagnosis of Indeterminate Adrenal Tumors on Conventional Imaging: A French Prospective Multicentric Study
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adrenal Tumors
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2011-01-27
Enrollment: 87
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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).

Eligibility 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.

Primary outcomes:
measure: diagnostic accuracy of FDG-PETparticularly the SUVmax tumor/liver ratio, in the diagnosis of indeterminate adrenal tumors on conventional imaging.
timeFrame: 3 YEARS
Secondary outcomes:
measure: assess the diagnostic accuracy of the tumorSUVmax, and SUVmax of the tumor/mean SUV of the liver.
timeFrame: 3 YEARS
measure: To evaluate the relationship between SUVmax tumor/liver ratio and Weiss score
timeFrame: 3 years
measure: To evaluate the impact of the use of FDG-PET on the treatment options
timeFrame: 3 years
measure: To evaluate the economic impact of FDG-PET in the management of indeterminate adrenal tumors (ancillary study).
timeFrame: 3 years
Other outcomes:
Locations:
city: Marseille
country: France
facility: Assistance Publique Hopitaux de Marseille
Study officials:
affiliation: Assistance Publique hôpitaux de Marseille
name: DAVID TAEB
role: PRINCIPAL_INVESTIGATOR
References:
citation: Guerin C, Pattou F, Brunaud L, Lifante JC, Mirallie E, Haissaguerre M, Huglo D, Olivier P, Houzard C, Ansquer C, Hindie E, Loundou A, Archange C, Tabarin A, Sebag F, Baumstarck K, Taieb D. Performance of 18F-FDG PET/CT in the Characterization of Adrenal Masses in Noncancer Patients: A Prospective Study. J Clin Endocrinol Metab. 2017 Jul 1;102(7):2465-2472. doi: 10.1210/jc.2017-00254.