11C Methionine PET for the Detection of Hyperfunctional Parathyroid Tissues

Phase 2

• Conditions: Primary Hyperparathyroidism
• Interventions: Radiation: 11C-Methionine PET/CT scanning; Radiation: 18F-FDG PET/CT scanning; Radiation: SPECT-CT scanning

• Registration Number: NCT01783002
• Lead Sponsor: University of British Columbia

Brief 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.

Study Timeline

• Study First Submitted: 2013-01-04
• Study First Submitted QC: 2013-01-31
• Study First Posted: 2013-02-04
• Study Start: 2014-05
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-16
• Last Update Posted: 2015-09-18
• Primary Completion: 2018-03
• Study Completion: 2018-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Adults > age 18;
• Able to provide written informed consent;
• Subjects with biochemical evidence, including elevated serum calcium and PTH levels, of primary hyperparathyroidism.

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Exclusion Criteria

• Subjects with previous successful parathyroidectomy and parathyroid tissue reimplantation;
• Pregnancy;
• Subjects who are unable to tolerate the physical/logistical requirements of completing two PET/CT scans, including lying still for a prolonged period of time and receiving two intravenous injections.
• Subjects who exceed the safe weight limit of the PET/CT bed (204.5 kg) or who cannot fit through the PET/CT machine (diameter 70cm).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Primary hyperparathyroidism	11C-Methionine PET/CT scanning	Subjects with biochemical evidence, including elevated serum calcium and PTH levels, of primary hyperparathyroidism. All patients will undergo 11C-methionine PET/CT, SPECT-CT and 18F-FDG PET/CT scanning.
Primary hyperparathyroidism	18F-FDG PET/CT scanning	Subjects with biochemical evidence, including elevated serum calcium and PTH levels, of primary hyperparathyroidism. All patients will undergo 11C-methionine PET/CT, SPECT-CT and 18F-FDG PET/CT scanning.
Primary hyperparathyroidism	SPECT-CT scanning	Subjects with biochemical evidence, including elevated serum calcium and PTH levels, of primary hyperparathyroidism. All patients will undergo 11C-methionine PET/CT, SPECT-CT and 18F-FDG PET/CT scanning.

Primary Outcome Measures

Name	Time	Method
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 hyperparathyroidism	Patient will undergo the scans at baseline	Sensitivity is the percentage of patients that were correctly identified to have an abnormal parathyroid gland by the imaging studies.
To compare the specificity of11C-MET PET/CT, SPECT-CT and 18F-FDG PET/CT in the detection of pathologic parathyroid glands in patients with primary hyperparathyroidism	Patient will undergo the scans at baseline	Specificity is defined as the percentage of patients that were correctly rejected for having an abnormal parathyroid gland by the imaging studies.

Secondary Outcome Measures

Name	Time	Method
To evaluate the safety profile of 11C-MET PET/CT.	Up to 2 weeks	All adverse events will be recorded. An Adverse Event (AE) is any untoward, undesired, unplanned medical occurrence in a participant and does not necessarily have a causal relationship with the study intervention. Expected adverse events from PET/CT scans include bruising, bleeding or infection at the site of intravenous radiotracer injection. Other expected adverse events include feeling of discomfort or claustrophobia from being in the scanner.

Trial Locations

Locations (1)

British Columbia Cancer Agency; 🇨🇦 Vancouver, British Columbia, Canada