Performance of 18F-Fluorodeoxyglucose Positron Emission Tomography (FDG-PET) in the Diagnosis of Indeterminate Adrenal Tumors on Conventional Imaging: A French Prospective Multicentric Study
2 other identifiers
interventional
87
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2011
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 13, 2011
CompletedFirst Posted
Study publicly available on registry
January 27, 2011
CompletedStudy Start
First participant enrolled
February 4, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 10, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
April 5, 2023
CompletedApril 6, 2023
April 1, 2023
2.7 years
January 13, 2011
April 5, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
diagnostic accuracy of FDG-PETparticularly the SUVmax tumor/liver ratio, in the diagnosis of indeterminate adrenal tumors on conventional imaging.
3 YEARS
Secondary Outcomes (4)
assess the diagnostic accuracy of the tumorSUVmax, and SUVmax of the tumor/mean SUV of the liver.
3 YEARS
To evaluate the relationship between SUVmax tumor/liver ratio and Weiss score
3 years
To evaluate the impact of the use of FDG-PET on the treatment options
3 years
To evaluate the economic impact of FDG-PET in the management of indeterminate adrenal tumors (ancillary study).
3 years
Study Arms (1)
adrenal tumors
EXPERIMENTALadrenal tumors
Interventions
Eligibility Criteria
You may qualify if:
- Adult ≥ 18 yrs, male or female;
- Patient insured with public health care system ;
- Patient who accept to participate to the study and to sign the consent document form.
You may not qualify if:
- Technical inability to perform FDG-PET.
- Patient's death before final diagnosis.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Assistance Publique Hopitaux de Marseille
Marseille, 13354, France
Related Publications (1)
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.
PMID: 28431167DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
DAVID TAEB
Assistance Publique hôpitaux de Marseille
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 13, 2011
First Posted
January 27, 2011
Study Start
February 4, 2011
Primary Completion
October 10, 2013
Study Completion
April 5, 2023
Last Updated
April 6, 2023
Record last verified: 2023-04