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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

Primary Purpose

Adrenal Tumors

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
FDG-PET scan
Sponsored by
Assistance Publique Hopitaux De Marseille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Adrenal Tumors

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Assistance Publique Hopitaux de Marseille

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

adrenal tumors

Arm Description

adrenal tumors

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

assess the diagnostic accuracy of the tumorSUVmax, 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).

Full Information

First Posted
January 13, 2011
Last Updated
April 5, 2023
Sponsor
Assistance Publique Hopitaux De Marseille
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1. Study Identification

Unique Protocol Identification Number
NCT01284829
Brief 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
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
February 4, 2011 (Actual)
Primary Completion Date
October 10, 2013 (Actual)
Study Completion Date
April 5, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique Hopitaux De Marseille

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adrenal Tumors

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
87 (Actual)

8. Arms, Groups, and Interventions

Arm Title
adrenal tumors
Arm Type
Experimental
Arm Description
adrenal tumors
Intervention Type
Other
Intervention Name(s)
FDG-PET scan
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
assess the diagnostic accuracy of the tumorSUVmax, and SUVmax of the tumor/mean SUV of the liver.
Time Frame
3 YEARS
Title
To evaluate the relationship between SUVmax tumor/liver ratio and Weiss score
Time Frame
3 years
Title
To evaluate the impact of the use of FDG-PET on the treatment options
Time Frame
3 years
Title
To evaluate the economic impact of FDG-PET in the management of indeterminate adrenal tumors (ancillary study).
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
DAVID TAEB
Organizational Affiliation
Assistance Publique hôpitaux de Marseille
Official's Role
Principal Investigator
Facility Information:
Facility Name
Assistance Publique Hopitaux de Marseille
City
Marseille
ZIP/Postal Code
13354
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
28431167
Citation
Guerin C, Pattou F, Brunaud L, Lifante JC, Mirallie E, Haissaguerre M, Huglo D, Olivier P, Houzard C, Ansquer C, Hindie E, Loundou A, Archange C, Tabarin A, Sebag F, Baumstarck K, Taieb D. Performance of 18F-FDG PET/CT in the Characterization of Adrenal Masses in Noncancer Patients: A Prospective Study. J Clin Endocrinol Metab. 2017 Jul 1;102(7):2465-2472. doi: 10.1210/jc.2017-00254.
Results Reference
derived

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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

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