Status:
COMPLETED
To Compare Safety and the General Imaging Pattern of Cyclotron Produced Technetium vs. Generator Produced Technetium in Patients With Thyroid Cancer
Lead Sponsor:
AHS Cancer Control Alberta
Collaborating Sponsors:
Natural Resources, Canada
Edmonton PET Centre
Conditions:
Thyroid Neoplasms
Eligibility:
All Genders
18-79 years
Phase:
PHASE1
Brief 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 th...
Detailed Description
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 thera...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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 the study
- Karnofsky Performance Scale score \<50
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2015
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01437254
Start Date
October 1 2011
End Date
January 1 2015
Last Update
November 14 2017
Active Locations (1)
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1
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2