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

Thyroid Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01437254
• Other study ID #: DX-CPERT-001
• Status: Completed
• Phase: Phase 1
• First received: September 19, 2011
• Last updated: November 10, 2017
• Start date: October 2011
• Est. completion date: January 2015

Study information

• Verified date: November 2017
• Source: AHS Cancer Control Alberta
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: January 2015
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 79 Years

Eligibility

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

Related Conditions & MeSH terms

• Thyroid Diseases
• Thyroid Neoplasms

Intervention

Drug:
• CPERT
Single 340 MBq CPERT scan in first 10 subjects
• GPERT
Single 340 MBq GPERT scan in up to 20 case-matched controls

Locations

Country	Name	City	State
Canada	Cross Cancer Institute	Edmonton	Alberta

Sponsors (3)

Lead Sponsor	Collaborator
AHS Cancer Control Alberta	Edmonton PET Centre, Natural Resources, Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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