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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


N/A
18 Years
N/A
Open (Enrolling)
Both
Adrenal Gland Neoplasms

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Trial Information

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


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).


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

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

Outcome Time Frame:

3 YEARS

Safety Issue:

No

Principal Investigator

DAVID TAEB

Investigator Role:

Principal Investigator

Investigator Affiliation:

Assistance Publique hôpitaux de Marseille

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

2010-A00705-34

NCT ID:

NCT01284829

Start Date:

November 2010

Completion Date:

May 2014

Related Keywords:

  • Adrenal Gland Neoplasms
  • Adrenal Gland Neoplasms
  • Neoplasms

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