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

A Phase I Study of Cyclotron-produced Tc-99m Pertechnetate (CPERT) in Patients With Thyroid Cancer

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.

Study Overview

• Status: Completed
• Conditions: Thyroid Neoplasms
• Intervention / Treatment: Drug: CPERT; Drug: GPERT

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 therapy. The first 10 subjects will receive a CPERT whole body scan, and and 20 subsequent case-matched controls (2 for each CPERT subject, matched for age and gender) will receive a GPERT whole body scan. CPERT safety will be assessed by pre-injection and post-imaging collection of vital signs and blood samples (haematology and biochemistry). Adverse event collection will be done for both CPERT and GPERT subjects. The whole body biodistribution pattern of CPERT will be qualitatively compared to GPERT by two independent and blinded Nuclear Medicine physicians.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 1

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T6G 1Z2
      • Cross Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 79 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm Number 1 CPERT; 1 CPERT scan, blood and vital sign collection	Drug: CPERT; Single 340 MBq CPERT scan in first 10 subjects
Active Comparator: Arm Number 2 GPERT; 1 GPERT Scan	Drug: GPERT; Single 340 MBq GPERT scan in up to 20 case-matched controls

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety of CPERT	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.	7 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of general biodistribution of CPERT and GPERT.	The whole body biodistribution pattern of CPERT will be compared to GPERT using two independent and blinded Nuclear Medicine physicians.	7 months

Collaborators and Investigators

• Sponsor: AHS Cancer Control Alberta
• Collaborators: Natural Resources, Canada; Edmonton PET Centre
• Investigators: Principal Investigator: Alexander McEwan, MB, FCRPC, Professor, Department of Oncology

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2011
• Primary Completion (Actual): April 1, 2012
• Study Completion (Actual): January 1, 2015

Study Registration Dates

• First Submitted: September 19, 2011
• First Submitted That Met QC Criteria: September 19, 2011
• First Posted (Estimate): September 20, 2011

Study Record Updates

• Last Update Posted (Actual): November 14, 2017
• Last Update Submitted That Met QC Criteria: November 10, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Keywords: thyroidectomy; 99mTc Pertechnetate
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Endocrine System Diseases; Endocrine Gland Neoplasms; Head and Neck Neoplasms; Thyroid Diseases; Thyroid Neoplasms
• Other Study ID Numbers: DX-CPERT-001