Combined 18F-Fluorodeoxyglucose (FDG) Positron Emission Tomography (PET) and Metomidate Imaging for Adrenal Neoplasia (FAMIAN-Study) - a Diagnostic Study

• Conditions: indeterminate adrenal neoplasias; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]

• Registration Number: EUCTR2012-003604-13-DE
• Lead Sponsor: niversity Hospital Wuerzburg

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-06-10
• Last Update Posted: 6 October 2015

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 220

Inclusion Criteria

Patients with a solid indeterminate adrenal mass scheduled for surgery (within 3 months) and a diameter > 3 cm or an increase in tumor diameter of > 1 cm in follow-up imaging. In unenhanced computerized tomography (CT) the attenuation value of the adrenal tumor is = 10 Hounsfield units (HU).
Age = 30 years.
Written informed consent.
ECOG performance status 0-2
Effective contraception in pre-menopausal female patients
Negative pregnancy test
Patient´s signed written informed consent
Ability to comply with the protocol procedures

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 150
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 70

Exclusion Criteria

Pregnancy or breast feeding
Patient unfit or unwilling to undergo surgery
Biochemical evidence of pheochromocytoma
Diagnosis of primary hyperaldosteronism
Overt adrenal Cushing’s syndrome or morning serum cortisol after dexamethasone (1 mg at 23.00 h) > 5 µg/dl (140 nmol/l) AND urinary free cortisol levels twice the upper limit of normal

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Evaluation of the utility of combined FDG-PET and [123I]iodometomidate imaging for non-invasive characterization of indeterminate adrenal neoplasias<br><br>Demonstration of the effectiveness of a non-invasive test for benign adrenocortical adenomas;Secondary Objective: Evaluation of the utility of combined FDG-PET and [123I]iodometomidate imaging for diagnosis of ACC versus non-ACC<br>Evaluation of FDG-PET as a predictor of malignancy in adrenal neoplasia<br>Cost effectiveness analysis (compared with with avoidable costs for surgery);Primary end point(s): Primary efficacy endpoint: <br>Classification AA/non-AA and diagnostic test result AA+/AA- for specificity (rate estimation) of the diagnostic AA test and for the likelihood ratio of a positive diagnostic test (using rate estimation of the sensitivity). <br>AA=adrenocortical adenoma;Timepoint(s) of evaluation of this end point: 55-60 months after start of the trial

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Sensitivity of the diagnostic AA test and likelihood ratio of a negative diagnostic AA test, classification of indeterminate adrenal neoplasias for a priori rates of AA, adrenocortical cancer (ACC) and other benign as well as malignant indeterminate adrenal neoplasias. Detection rates similar to sensitivity and specificity for ACC and indeterminate adrenal neoplasias other than AA and ACC of combined 18F-FDG-PET imaging and 123I-Iodometomidate imaging in identifying ACC. Predictive values <br>will be determined and economic analysis of cost effectiveness of diagnostic evaluation versus surgery for all indeterminate lesions will be performed. ;Timepoint(s) of evaluation of this end point: 55-60 months after start of the trial