NCT02514187

A Blinded Study Evaluating the Accuracy and Safety of Cyclotron-produced 99mTc in Adult Patients

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: British Columbia Cancer Agency · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate technetium-99m (99mTc) pertechnetate produced by a cyclotron as a replacement for 99mTc pertechnetate obtained from a generator containing the parent isotope Molybdenum-99 (99Mo). 99mTc pertechnetate is currently used in nuclear medicine departments across the country. 99Mo is produced by a number of ageing nuclear reactors across the world and severe shortages of the isotope have occurred in the past few years. Cyclotron-produced 99mTc offers an alternative decentralized production method on a regional basis. Since the manufacturing process is different, the safety and efficacy of cyclotron-produced 99mTc pertechnetate must be evaluated in human subjects to enable its routine clinical use.

Conditions

• Hyperthyroidism

Interventions

Type	Name	Description
DRUG	Cyclotron-produced 99mTc	Each research subject will serve as his/her own control, and will undergo imaging using both generator- and cyclotron-produced 99mTc. The study will follow the usual clinical procedure for routine imaging in the nuclear medicine department. All subjects will be contacted by phone or in person the day following the injection of both generator and cyclotron-produced 99mTc to monitor for potential adverse events.
DRUG	Generator-produced 99mTc	Each research subject will serve as his/her own control, and will undergo imaging using both generator- and cyclotron-produced 99mTc. The study will follow the usual clinical procedure for routine imaging in the nuclear medicine department. All subjects will be contacted by phone or in person the day following the injection of both generator and cyclotron-produced 99mTc to monitor for potential adverse events.

Timeline

• Start date: 2015-10-01
• Primary completion: 2017-04-01
• Completion: 2017-04-01
• First posted: 2015-08-03
• Last updated: 2023-02-21

Locations

3 sites across 1 country: Canada