A Prospective Phase I Study of Cyclotron-produced Tc-99m Pertechnetate (CPERT) in Patients With Thyroid Cancer
This trial is active, not recruiting.
|Sponsor||AHS Cancer Control Alberta|
|Collaborator||Natural Resources, Canada|
|Start date||October 2011|
|End date||September 2015|
|Trial size||30 participants|
|Trial identifier||NCT01437254, DX-CPERT-001/Ethics 25831|
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.
|Endpoint classification||safety study|
|Intervention model||parallel assignment|
1 CPERT scan, blood and vital sign collection
1 GPERT Scan
Safety of CPERT
time frame: 7 months
Comparison of general biodistribution of CPERT and GPERT.
time frame: 7 months
Male or female participants from 18 years up to 79 years old.
- If female of child-bearing potential and outside of the window of 10 days since the first day of the last menstrual period, a negative pregnancy test is required.
- Have confirmed well differentiated thyroid cancer, post-thyroidectomy and pre-RAI
- Biochemical parameters as measured are required to be within 5 times the normal limits for age
- white blood cell count (WCB) > 3.0/µL
- absolute neutrophil count (ANC) > 1.5/µL
- Platelets > 75,000/µL
- Hemoglobin > 10 g/dL
- Able and willing to follow instructions and comply with the protocol
- Provide written informed consent prior to participation in the study
- Karnofsky Performance Scale score of 50 - 100
- Nursing or pregnant females
- Biochemical parameters as measured outside 5 times the normal limits for age within 14 days of the pre-treatment scan
- White blood cell count (WCB < 3.0/µL)
- absolute neutrophil count (ANC) < 1.5/µL
- Platelets < 75,000/µL
- Haemoglobin < 10 g/dL
- unable and unwilling to follow instructions and comply with the protocol
- unable or unwilling to provide written informed consent prior to participation in teh study
- Karnofsky Performance Scale score <50
|Official title||To Compare Safety and the General Imaging Pattern of Cyclotron Produced Technetium vs. Generator Produced Technetium in Patients With Thyroid Cancer|
|Principal investigator||AJB McEwan, Msc, MB, BS|
|Description||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.|
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