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

AHS Cancer Control Alberta

Status and phase: Completed; Phase 1

Conditions: Thyroid Neoplasms

Treatments: Drug: CPERT; Drug: GPERT

Study type: Interventional

Funder types: Other

Identifiers

NCT01437254

DX-CPERT-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 79 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 2 patient groups

Arm Number 1 CPERT

Experimental group

Description:

1 CPERT scan, blood and vital sign collection

Treatment:

Drug: CPERT

Arm Number 2 GPERT

Active Comparator group

Description:

1 GPERT Scan

Treatment:

Drug: GPERT