Clinical trial NCT01783002: 11C Methionine PET for the Detection of Hyperfunctional Parathyroid Tissues
Official title: Pre-operative Parathyroid Imaging: a Comparison of 11C-Methionine PET, 18F-FDG PET AND SPEC-CT for the Detection of Hyperfunctional Parathyroid Tissues
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Primary Hyperparathyroidism
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: British Columbia Cancer Agency
First posted: 2013-02-04
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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.

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).

Primary outcomes:
measure: 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
timeFrame: Patient will undergo the scans at baseline
measure: 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
timeFrame: Patient will undergo the scans at baseline
Secondary outcomes:
measure: To evaluate the safety profile of 11C-MET PET/CT.
timeFrame: Up to 2 weeks
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: British Columbia Cancer Agency
state: British Columbia
Study officials:
affiliation: University of British Columbia; Vancouver General Hospital
name: Donald W Anderson, MD, FRCSC
role: PRINCIPAL_INVESTIGATOR
affiliation: British Columbia Cancer Agency
name: Don Wilson, MD, FRCPC
role: PRINCIPAL_INVESTIGATOR
References: