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11C Methionine PET for the Detection of Hyperfunctional Parathyroid Tissues

This study is not yet open for participant recruitment. (see Contacts and Locations)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
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         
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         
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
Endocrine System Diseases
Parathyroid Diseases
Fluorodeoxyglucose F18
Diagnostic Uses of Chemicals
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Radiopharmaceuticals

ClinicalTrials.gov processed this record on November 25, 2014