Overview

This trial is active, not recruiting.

Condition thyroid neoplasms
Treatments cpert, gpert
Phase phase 1
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

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety study
Intervention model parallel assignment
Masking open label
Primary purpose diagnostic
Arm
(Experimental)
1 CPERT scan, blood and vital sign collection
cpert
Single 340 MBq CPERT scan in first 10 subjects
(Active Comparator)
1 GPERT Scan
gpert
Single 340 MBq GPERT scan in up to 20 case-matched controls

Primary Outcomes

Measure
Safety of CPERT
time frame: 7 months

Secondary Outcomes

Measure
Comparison of general biodistribution of CPERT and GPERT.
time frame: 7 months

Eligibility Criteria

Male or female participants from 18 years up to 79 years old.

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

Additional Information

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 [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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2014.
Information provided to ClinicalTrials.gov by AHS Cancer Control Alberta.