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 Overview
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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.

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).

Official Title
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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

Conditions
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Adrenal Tumors

Intervention / Treatment
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* Other: FDG-PET scan


Participation Criteria
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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. Exclusion Criteria: Technical inability to perform FDG-PET. Patient's death before final diagnosis.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: adrenal tumors<br>adrenal tumors | Other: FDG-PET scan<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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 |