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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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Assistance Publique Hopitaux De Marseille
Sponsor:
Information provided by (Responsible Party):
Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier:
NCT01284829
First received: January 13, 2011
Last updated: August 28, 2014
Last verified: August 2014

January 13, 2011
August 28, 2014
November 2010
November 2015   (final data collection date for primary outcome 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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01284829 on ClinicalTrials.gov Archive Site
  • assess the diagnostic accuracy of the tumorSUVmax, and SUVmax of the tumor/mean SUV of the liver. [ Time Frame: 3 YEARS ] [ Designated as safety issue: No ]
  • To evaluate the relationship between SUVmax tumor/liver ratio and Weiss score [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • To evaluate the impact of the use of FDG-PET on the treatment options [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • To evaluate the economic impact of FDG-PET in the management of indeterminate adrenal tumors (ancillary study). [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Performance of 18F-Fluorodeoxyglucose Positron Emission Tomography (FDG-PET) in the Diagnosis of Indeterminate Adrenal Tumors on Conventional Imaging: A French Prospective Multicentric Study
Performance of 18F-Fluorodeoxyglucose Positron Emission Tomography (FDG-PET) in the Diagnosis of Indeterminate Adrenal Tumors on Conventional Imaging: A French Prospective Multicentric Study

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.

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).
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Adrenal Tumors
Other: FDG-PET scan
Experimental: adrenal tumors
Intervention: Other: FDG-PET scan
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
165
November 2015
November 2015   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact: DAVID TAEB 0491385904 david.taeb@ap-hm.fr
Contact: DAVID TAEB
France
 
NCT01284829
2010-A00705-34, 2010 08
No
Assistance Publique Hopitaux De Marseille
Assistance Publique Hopitaux De Marseille
Not Provided
Principal Investigator: DAVID TAEB Assistance Publique hôpitaux de Marseille
Assistance Publique Hopitaux De Marseille
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP