Performance of 18F-Fluorodeoxyglucose Positron Emission Tomography (FDG-PET) in the Diagnosis of Indeterminate Adrenal Tumors on Conventional Imaging: A French Prospective Multicentric Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 87
- Locations
- 1
- Primary Endpoint
- diagnostic accuracy of FDG-PETparticularly the SUVmax tumor/liver ratio, in the diagnosis of indeterminate adrenal tumors on conventional imaging.
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
adrenal tumors
adrenal tumors
Intervention: FDG-PET scan (Other)
Outcomes
Primary Outcomes
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
- To evaluate the relationship between SUVmax tumor/liver ratio and Weiss score(3 years)
- assess the diagnostic accuracy of the tumorSUVmax, and SUVmax of the tumor/mean SUV of the liver.(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)