A Prospective Phase I Study of Cyclotron-produced Tc-99m Pertechnetate (CPERT) in Patients With Thyroid Cancer
Patients who have had a thyroidectomy for cancer routinely have a Tc-99m Pertechnetate [GPERT] scan at the Cross Cancer Institute to check for thyroid tissue remnants prior to radioactive iodine therapy. The first 10 subjects will receive one CPTERT [cyclotron made] Tc-99m Pertechnetate scan after surgery. Vital signs and blood work, pre-injection and post-imaging will be done. The second group of 20 subjects (2 for each CPERT subject) will be matched as to age and gender and have a GPERT scan for qualitative comparison.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||To Compare Safety and the General Imaging Pattern of Cyclotron Produced Technetium vs. Generator Produced Technetium in Patients With Thyroid Cancer|
- Safety of CPERT [ Time Frame: 7 months ] [ Designated as safety issue: Yes ]CPERT safety will be assessed by evaluation of vital signs (pre-injection and post-imaging), blood haematology (pre-injection and post-imaging), SMA-12 clinical biochemistry profile (pre-injection and post-imaging) and collection of adverse events.
- Comparison of general biodistribution of CPERT and GPERT. [ Time Frame: 7 months ] [ Designated as safety issue: No ]The whole body biodistribution pattern of CPERT will be compared to GPERT using two independent and blinded Nuclear Medicine physicians.
|Study Start Date:||October 2011|
|Estimated Study Completion Date:||March 2013|
|Estimated Primary Completion Date:||March 2013 (Final data collection date for primary outcome measure)|
Experimental: Arm Number 1 CPERT
1 CPERT scan, blood and vital sign collection
Single 340 MBq CPERT scan in first 10 subjects
Active Comparator: Arm Number 2 GPERT
1 GPERT Scan
Single 340 MBq GPERT scan in up to 20 case-matched controls
The Canadian Government supports R&D into alternative methods of medical isotope production that  do not require the construction of new nuclear reactors,  are not dependent on government subsidies and  will lead to a RP market. The cyclotron production model of pertechnetate (CPERT) has received significant validation. The University of Alberta's Edmonton PET Center and the ERC is a cyclotron/radiopharmacy unit, providing a safe, cost effective, unsubsidized and reliable supply of RPs.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01437254
|Cross Cancer Institute|
|Edmonton, Alberta, Canada, T6G 1Z2|
|Principal Investigator:||AJB McEwan, Msc, MB, BS||FRCP Canada|