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.
Verified March 2011 by Assistance Publique Hopitaux De Marseille
Sponsor:
Information provided by:
Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier:
NCT01284829
First received: January 13, 2011
Last updated: March 31, 2011
Last verified: March 2011
  Purpose

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.


Condition Intervention
Adrenal Gland Neoplasms
Other: FDG-PET scan

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
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

Resource links provided by NLM:


Further study details as provided by Assistance Publique Hopitaux De Marseille:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 165
Study Start Date: November 2010
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: adrenal tumors Other: FDG-PET scan

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01284829

Contacts
Contact: DAVID TAEB 0491385904 david.taeb@ap-hm.fr
Contact: DAVID TAEB

Locations
France
Assistance Publique Hopitaux de Marseille Recruiting
Marseille, France, 13354
Contact: david taeb    0491385904    david.taeb@ap-hm.fr   
Principal Investigator: david taeb         
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
Investigators
Principal Investigator: DAVID TAEB Assistance Publique hôpitaux de Marseille
  More Information

No publications provided

Responsible Party: Bernard BELAIGUES
ClinicalTrials.gov Identifier: NCT01284829     History of Changes
Other Study ID Numbers: 2010-A00705-34, 2010 08
Study First Received: January 13, 2011
Last Updated: March 31, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Adrenal Gland Neoplasms
Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Adrenal Gland Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on April 17, 2014