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Completed

NCT Number: NCT01437254

To Compare Safety and the General Imaging Pattern of Cyclotron Produced Technetium vs. Generator Produced Technetium 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.

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Key information

Conditions

Thyroid Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Head and Neck Neoplasms Neoplasms Neoplasms by Site Thyroid Diseases

Age range

18 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Cross Cancer Institute

Edmonton, Alberta, T6G 1Z2, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CPERT

Drug

Single 340 MBq CPERT scan in first 10 subjects

GPERT

Drug

Single 340 MBq GPERT scan in up to 20 case-matched controls

Primary outcomes

  1. Safety of CPERT

    Time frame: 7 months

    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.

Secondary outcomes

  1. Comparison of general biodistribution of CPERT and GPERT.

    Time frame: 7 months

    The whole body biodistribution pattern of CPERT will be compared to GPERT using two independent and blinded Nuclear Medicine physicians.

Sponsors and collaborators

Lead sponsor

AHS Cancer Control Alberta

Other

Collaborators

  • Edmonton PET Centre
  • Natural Resources, Canada

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2015
First posted
Sep 20, 2011
Registry last updated
Nov 14, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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