Limited Neck FDG-PET Imaging for Indeterminate Thyroid Nodules
While FNA is a sensitive test for diagnosing thyroid tumors, it cannot differentiate benign
from malignant follicular nodules and sometimes yields equivocal results due to inadequate
sampling or indeterminate cytology. The standard of care for patients with equivocal or
follicular histology is surgical removal of these nodules, most of which are benign in
nature. FDG-PET, as evidenced by our prior experience and studies from other groups, may
have application in discriminating benign from malignant disease in these patients with
equivocal or follicular FNA results using standardized uptake value determination. We have
demonstrated the feasibility and preliminary clinical utility of using limited neck FDG-PET
exams in patients with indeterminate thyroid nodules in a pilot study. The purpose of this
trial is to prospectively evaluate a larger series of patients with equivocal or follicular
histology on FNA to more accurately define the sensitivity and specificity of FDG-PET for
diagnostic imaging of these nodules. In addition, the utility of this modality in
identifying metastatic foci in patients with thyroid cancer having follicular or equivocal
histology on FNA will be assessed. If the sensitivity and specificity of this modality are
determined to be high (≥95%) for diagnosing malignant nodules in these patients, many
patients with benign disease may potentially benefit by avoiding unnecessary operations.
Interventional
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Determine the sensitivity and specificity of FDG-PET in identifying malignant thyroid nodules of follicular or indeterminate cytology.
Approximately 6 weeks after surgery
No
Jeffrey F Moley, MD
Principal Investigator
Washington University School of Medicine
United States: Institutional Review Board
04-0757 / 201103045
NCT00537797
August 2004
September 2013
Name | Location |
---|---|
Washington University School of Medicine | Saint Louis, Missouri 63110 |
St. Louis University School of Medicine | Saint Louis, Missouri 63104 |
VAMC | Kansas City, Missouri |