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

Adrenal Tumors Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01284829
• Other study ID #: 2010-A00705-34
• Secondary ID: 2010 08
• Status: Completed
• Phase: N/A
• Start date: February 4, 2011
• Est. completion date: April 5, 2023

Study information

• Verified date: April 2023
• Source: Assistance Publique Hopitaux De Marseille
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 87
• Est. completion date: April 5, 2023
• Est. primary completion date: October 10, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Adrenal Gland Neoplasms
• Adrenal Tumors

Intervention

Other:
• FDG-PET scan

Locations

Country	Name	City	State
France	Assistance Publique Hopitaux de Marseille	Marseille

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	diagnostic accuracy of FDG-PETparticularly the SUVmax tumor/liver ratio, in the diagnosis of indeterminate adrenal tumors on conventional imaging.		3 YEARS
Secondary	assess the diagnostic accuracy of the tumorSUVmax, and SUVmax of the tumor/mean SUV of the liver.		3 YEARS
Secondary	To evaluate the relationship between SUVmax tumor/liver ratio and Weiss score		3 years
Secondary	To evaluate the impact of the use of FDG-PET on the treatment options		3 years
Secondary	To evaluate the economic impact of FDG-PET in the management of indeterminate adrenal tumors (ancillary study).		3 years