NCT01783002

11C Methionine PET for the Detection of Hyperfunctional Parathyroid Tissues

Pre-operative Parathyroid Imaging: a Comparison of 11C-Methionine PET, 18F-FDG PET AND SPEC-CT for the Detection of Hyperfunctional Parathyroid Tissues

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: University of British Columbia · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The overall sensitivity and specificity of 11C-MET PET/CT is superior to 18F-FDG PET/CT and conventional SPECT-CT for the detection of abnormal parathyroid glands.

Detailed description

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 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 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 hyperparathyroidism. STUDY POPULATION Number of Subjects: 50 patients Number of groups: 1: 50 with primary hyperparathyroidism. Age/Gender: Age greater than or equal to 19 years / Male and Female Study specific requirements: Subjects with clinically suspected primary 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 hyperparathyroidism. Safety: Vital signs before and following 11C-MET administration; adverse events collection.

Conditions

• Primary Hyperparathyroidism

Interventions

Type	Name	Description
RADIATION	11C-Methionine PET/CT scanning	PET with the radiopharmaceutical carbon-11 methionine (11C-MET) has been considered to improve diagnosis due to a superior spatial resolution and higher specificity compared to other radiotracers such as 18F-FDG. For the 11C-MET PET/CT, the patient will receive an intravenous bolus injection of 11C-MET as manufactured at the BCCA production facility at a dose of 6 (0.16 mCi) MBq per kilogram but not to exceed 555 MBq (15 mCi).
RADIATION	18F-FDG PET/CT scanning	For PET/CT scans, the patient will first receive an intravenous bolus injection of 18F-FDG as manufactured at the BCCA production facility in a dose determined by body weight but not to exceed 521 MBq (14.1 mCi). Our standard adult prescription (70kg adult) for 18F-FDG is 296 MBq (8.0 mCi). The target dose for body scans is increased by 59.2 MBq (1.6 mCi) for every 20 kg increase in body weight to a maximum target dose of 474 MBq (12.8 mCi).
RADIATION	SPECT-CT scanning	For the SPECT-CT scan, each injection of intravenous 99mTc-MIBI is dosed at a maximum of 20 mCi (740MBq), as per usual standard of care. The energy window of each scan is at 140 keV, consistent with the standard of SPEC-CT imaging techniques.

Timeline

• Start date: 2014-05-01
• Primary completion: 2018-03-01
• Completion: 2018-07-01
• First posted: 2013-02-04
• Last updated: 2015-09-18

Locations

1 site across 1 country: Canada