Pre-operative Parathyroid Imaging: a Comparison of 11C-Methionine PET, 18F-FDG PET AND SPEC-CT for the Detection of Hyperfunctional Parathyroid Tissues
STUDY OBJECTIVES Primary: To compare the accuracy, sensitivity and specificity of
11C-methionine (MET) PET/CT and 99mTc-MIBI SPECT-CT in the detection of pathologic
parathyroid glands in patients with primary or tertiary hyperparathyroidism.
Secondary:To compare the accuracy, sensitivity and specificity of 11C-MET and 18F-FDG PET/CT
scans in the detection of pathologic parathyroid glands in patients with primary or tertiary
hyperparathyroidism.
STUDY DESIGN A phase II diagnostic imaging, single-centre study to compare the accuracy of
11C-MET PET/CT with standard 99mTc-MIBI SPECT-CT and with 18F-FDG PET/CT imaging in patients
with primary or tertiary hyperparathyroidism.
STUDY POPULATION Number of Subjects: 50 patients Number of groups: 2: 25 with primary
hyperparathyroidism, 25 with tertiary hyperparathyroidism.
Age/Gender: Age greater than or equal to 19 years / Male and Female Study specific
requirements: Subjects with clinically suspected primary or tertiary hyperparathyroidism who
require 99mTc-MIBI SPECT-CT parathyroid imaging.
INVESTIGATIONAL PRODUCT Product: 11C-Methionine Route of administration: Intravenous
Dosage(s) and frequency: Radioactive dose of 11C-Methionine of 6 MBq per kilogram body
weight per injection (maximum dose of 555 MBq); one injection per patient.
COMPARATOR PRODUCTS Product: 99mTc-Methoxyisobutylisonitrite; 18F-Fluorodeoxyglucose Route
of administration: Intravenous Dosage(s) and frequency: (1) Radioactive dose of
99mTc-Methoxyisobutylisonitrite of 555 - 740 MBq per injection; one injection per patient.
(2) Radioactive dose of 18F-Fluorodeoxyglucose of 296 - 521 MBq per injection; one injection
per patient.
EVALUATION CRITERIA Efficacy: The comparison of the accuracy, sensitivity, and specificity
of 11C-MET PET/CT with 99mTc-MIBI SPECT-CT and 18F-FDG PET/CT in the detection of pathologic
parathyroid glands in patients with primary or tertiary hyperparathyroidism.
Safety: Vital signs before and following 11C-MET administration; adverse events collection.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
To compare the sensitivity of 11C-MET PET/CT, SPECT-CT and 18F-FDG PET/CT in the detection of pathologic parathyroid glands in patients with primary or tertiary hyperparathyroidism
Sensitivity is the percentage of patients that were correctly identified to have an abnormal parathyroid gland by the imaging studies.
Patient will undergo the scans at baseline
No
Donald W Anderson, MD, FRCSC
Principal Investigator
University of British Columbia; Vancouver General Hospital
Canada: Health Canada
H12-01220
NCT01783002
March 2013
July 2014
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