Recruiting
Phase 2

11C Methionine PET

Sponsor:

University of British Columbia

Code:

NCT01783002

Conditions

Primary Hyperparathyroidism

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

11C-Methionine PET/CT scanning

18F-FDG PET/CT scanning

SPECT-CT scanning

Study Details

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.

Conditions

Primary Hyperparathyroidism

Study ID

NCT01783002

Start date

May, 2014

Status verified date

Sep, 2015

Completion date

Jul, 2018

Anticipated

Primary completion date

Mar, 2018

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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).

Study Design

Enrollment

50 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

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.

Interventions

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).

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).

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.

Primary 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 hyperparathyroidism [ Time Frame: Patient will undergo the scans at baseline ]
  • 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 [ Time Frame: Patient will undergo the scans at baseline ]

Central Contacts and Locations

Central contacts

Hayley Corbett

604-877-6000hayley.corbett@bccancer.bc.ca

Locations

British Columbia Cancer Agency

Recruiting

Vancouver, British Columbia, Canada, V5Z 4E6

Contacts

Hayley Corbett

604-877-6000hayley.corbett@bccancer.bc.ca

More Information

Sponsor

University of British Columbia

Last update posted

Sep 18, 2015

Last verified

Sep, 2015

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of British Columbia on 2015-09-18.