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NCT Number: NCT01284829

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.

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Key information

Conditions

Adrenal Tumors Adrenal Gland Diseases Adrenal Gland Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Assistance Publique Hopitaux de Marseille

Marseille, 13354, France

About this 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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

FDG-PET scan

Other

Primary outcomes

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

    Time frame: 3 YEARS

Secondary outcomes

  1. assess the diagnostic accuracy of the tumorSUVmax, and SUVmax of the tumor/mean SUV of the liver.

    Time frame: 3 YEARS

  2. To evaluate the relationship between SUVmax tumor/liver ratio and Weiss score

    Time frame: 3 years

  3. To evaluate the impact of the use of FDG-PET on the treatment options

    Time frame: 3 years

  4. To evaluate the economic impact of FDG-PET in the management of indeterminate adrenal tumors (ancillary study).

    Time frame: 3 years

Sponsors and collaborators

Lead sponsor

Assistance Publique Hopitaux De Marseille

Other

Registry information

Important dates

Study start
2011
Primary completion
2013
Study completion
2023
First posted
Jan 27, 2011
Registry last updated
Apr 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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