drugset / Trial / NCT02514187
A Blinded Study Evaluating the Accuracy and Safety of Cyclotron-produced 99mTc in Adult Patients
Completed
60 enrolled
British Columbia Cancer Agency
Canadian Institutes of Health Research (CIHR) · collabCentre for Probe Development and Commercialization · collabLondon Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's · collabNatural Resources, Canada · collabTRIUMF · collab
Non-randomizedParallel-groupTriple-blindDiagnostic
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.
Timeline
- Start
- 2015-10
- Primary completion
- 2017-04
- Completion
- 2017-04
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | 99mTc pertechnetate | Diagnostic / imaging agent | — | — |