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

• Status: Completed
• Trial end date: 2015-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AHS Cancer Control Alberta
• Collaborators: Edmonton PET Centre; Natural Resources, Canada
• Treatments: Sodium Pertechnetate Tc 99m

Criteria

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 the study

• Karnofsky Performance Scale score <50