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


Phase 2
18 Years
N/A
Not Enrolling
Both
Primary Hyperparathyroidism, Tertiary Hyperparathyroidism

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Trial Information

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.


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;

- Patients with biochemical evidence, including elevated serum calcium, PTH and
creatinine levels, of tertiary 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).

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome 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 or tertiary hyperparathyroidism

Outcome Description:

Sensitivity is the percentage of patients that were correctly identified to have an abnormal parathyroid gland by the imaging studies.

Outcome Time Frame:

Patient will undergo the scans at baseline

Safety Issue:

No

Principal Investigator

Donald W Anderson, MD, FRCSC

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of British Columbia; Vancouver General Hospital

Authority:

Canada: Health Canada

Study ID:

H12-01220

NCT ID:

NCT01783002

Start Date:

March 2013

Completion Date:

July 2014

Related Keywords:

  • Primary Hyperparathyroidism
  • Tertiary Hyperparathyroidism
  • Hyperparathyroidism
  • Hyperparathyroidism, Primary

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