11C Methionine PET for the Detection of Hyperfunctional Parathyroid Tissues

This study is not yet open for participant recruitment.
Verified January 2013 by University of British Columbia
Sponsor:
Collaborator:
British Columbia Cancer Agency
Information provided by (Responsible Party):
Donald W. Anderson, University of British Columbia
ClinicalTrials.gov Identifier:
NCT01783002
First received: January 4, 2013
Last updated: January 31, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention Phase
Primary Hyperparathyroidism
Tertiary Hyperparathyroidism
Radiation: 11C-Methionine PET/CT scanning
Radiation: 18F-FDG PET/CT scanning
Radiation: SPECT-CT scanning
Phase 2

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

Resource links provided by NLM:


Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • 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 [ Time Frame: Patient will undergo the scans at baseline ] [ Designated as safety issue: No ]
    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 or tertiary hyperparathyroidism [ Time Frame: Patient will undergo the scans at baseline ] [ Designated as safety issue: No ]
    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:
  • To evaluate the safety profile of 11C-MET PET/CT. [ Time Frame: Up to 2 weeks ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 50
Study Start Date: March 2013
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Primary hyperparathyroidism
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.
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).
Other Name: 11C-MET
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.
Experimental: Tertiary hyperparathyroidism
Patients with biochemical evidence, including elevated serum calcium, PTH and creatinine levels, of tertiary hyperparathyroidism. All patients will undergo 11C-methionine PET/CT, SPECT-CT and 18F-FDG PET/CT scanning.
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).
Other Name: 11C-MET
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.

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 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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;
  • 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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01783002

Contacts
Contact: Rui Jun Lin, MD 604-561-9854 jrlin13@gmail.com
Contact: Tarnjit Parhar 604-877-6000 ext 2818 tparhar@bccancer.bc.ca

Locations
Canada, British Columbia
Vancouver General Hospital Not yet recruiting
Vancouver, British Columbia, Canada, V5Z 1M9
Contact: Rui Jun Lin, MD    6045619854    jrlin13@gmail.com   
Principal Investigator: Donald W Anderson, MD, FRCRC         
British Columbia Cancer Agency Not yet recruiting
Vancouver, British Columbia, Canada, V5Z 4E6
Contact: Tarnjit Parhar    604-877-6000 ext 2818    tparhar@bccancer.bc.ca   
Sub-Investigator: Donald Wilson, MD, FRCPC         
Sponsors and Collaborators
University of British Columbia
British Columbia Cancer Agency
Investigators
Principal Investigator: Donald W Anderson, MD, FRCSC University of British Columbia; Vancouver General Hospital
Principal Investigator: Donald Wilson, MD, FRCPC British Columbia Cancer Agency
  More Information

No publications provided

Responsible Party: Donald W. Anderson, Clinical professor, University of British Columbia
ClinicalTrials.gov Identifier: NCT01783002     History of Changes
Other Study ID Numbers: H12-01220
Study First Received: January 4, 2013
Last Updated: January 31, 2013
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Hyperparathyroidism
Hyperparathyroidism, Primary
Parathyroid Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on April 15, 2014