To Compare Safety and the General Imaging Pattern of Cyclotron Produced Technetium vs. Generator Produced Technetium in Patients With Thyroid Cancer
18 Years
79 Years
Both
Thyroid Neoplasms
Trial Information
To Compare Safety and the General Imaging Pattern of Cyclotron Produced Technetium vs. Generator Produced Technetium in Patients With Thyroid Cancer
The Canadian Government supports R&D into alternative methods of medical isotope production
that [1] do not require the construction of new nuclear reactors, [2] are not dependent on
government subsidies and [3] 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.
Inclusion Criteria:
- 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 Criteria:
- 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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Outcome Measure:
Safety of CPERT
Outcome Description:
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.
Outcome Time Frame:
7 months
Safety Issue:
Yes
Principal Investigator
AJB McEwan, Msc, MB, BS
Investigator Role:
Principal Investigator
Investigator Affiliation:
FRCP Canada
Authority:
Canada: Health Canada
Study ID:
DX-CPERT-001/Ethics 25831
NCT ID:
NCT01437254
Start Date:
October 2011
Completion Date:
March 2013
Related Keywords:
- Thyroid Neoplasms
- 99mTc Pertechnetate
- thyroidectomy
- Neoplasms
- Thyroid Neoplasms
- Thyroid Diseases
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