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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by Assistance Publique Hopitaux De Marseille.
Recruitment status was  Recruiting
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 28, 2014