drugset / Trial / NCT01437254

To Compare Safety and the General Imaging Pattern of Cyclotron Produced Technetium vs. Generator Produced Technetium in Patients With Thyroid Cancer

NCT01437254 ↗

Non-randomizedParallel-groupSingle-blindDiagnostic

Summary

The cyclotron production model of Tc-99m pertechnetate (CPERT) has received significant validation in the independent expert review conducted by Natural Resources Canada (NRCan) in the follow up to the Chalk River crisis. The University of Alberta's Edmonton PET Centre and the Edmonton Radiopharmaceutical Centre is a cyclotron / radiopharmacy unit, providing a safe, cost effective, unsubsidized, and reliable supply of radiopharmaceuticals to hospitals and clinics in Edmonton and northern Alberta. A Phase I study is proposed to show safety of CPERT as well as comparability with generator-produced Tc-99m pertechnetate (GPERT) in subjects with well differentiated thyroid carcinoma post-thyroidectomy and prior to planned I-131 Iodide treatment.

Timeline

Start
2011-10
Primary completion
2012-04
Completion
2015-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator Tc-99m Pertechnetate Diagnostic / imaging agent 340 mbq —
Subject Tc-99m pertechnetate Unknown 340 mbq —

Indications