Performance of 18F-Fluorodeoxyglucose Positron Emission Tomography (FDG-PET) in the Diagnosis of Indeterminate Adrenal Tumors on Conventional Imaging: A French Prospective Multicentric Study
Information source: Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Adrenal Tumors
Intervention: FDG-PET scan (Other)
Phase: N/A
Status: Recruiting
Sponsored by: Assistance Publique Hopitaux De Marseille Official(s) and/or principal investigator(s): DAVID TAEB, Principal Investigator, Affiliation: Assistance Publique hôpitaux de Marseille
Overall contact: DAVID TAEB, Phone: 0491385904, Email: david.taeb@ap-hm.fr
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.
Clinical Details
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 design: Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Primary outcome: diagnostic accuracy of FDG-PETparticularly the SUVmax tumor/liver ratio, in the diagnosis of indeterminate adrenal tumors on conventional imaging.
Secondary outcome: 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).
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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
DAVID TAEB, Phone: 0491385904, Email: david.taeb@ap-hm.fr
Assistance Publique Hopitaux de Marseille, Marseille 13354, France; Recruiting david taeb, Phone: 0491385904, Email: david.taeb@ap-hm.fr david taeb, Principal Investigator
Additional Information
Starting date: November 2010
Last updated: August 28, 2014
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