A Study to Compare the Safety and Imaging Pattern of Cyclotron-produced Technetium (CTC) vs. Generator-produced Technetium (G-PERT) in People With Thyroid Disorders Who Need Surgery
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|ClinicalTrials.gov Identifier: NCT02980679|
Recruitment Status : Recruiting
First Posted : December 2, 2016
Last Update Posted : May 7, 2018
A 99mTc Pertechnetate (G-PERT) scan is a nuclear medicine test that can create an image of the thyroid gland and other organs. G-PERT is approved by Health Canada for the direct imaging and measurement of thyroid uptake.
Doctors and researchers at the University of Alberta have developed a new method of producing 99mTc Pertechnetate (called CTC). It is made in a cyclotron at the Medical Isotope and Cyclotron Facility (MICF) at the University of Alberta, Edmonton, Alberta. This new production method will provide another source of 99mTc Pertechnetate. The aim of this study is to confirm that CTC is safe and can be used interchangeably with G-PERT.
|Condition or disease||Intervention/treatment||Phase|
|Thyroid Gland Diseases||Drug: CTC Drug: G-PERT||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pivotal Phase III Study of Cyclotron-produced Tc-99m Pertechnetate (CTC) Compared to Generator-produced Tc-99m Pertechnetate (G-PERT) in Subjects With Thyroid Disorders|
|Actual Study Start Date :||March 3, 2017|
|Estimated Primary Completion Date :||July 2018|
|Estimated Study Completion Date :||December 2018|
Experimental: CTC and G-PERT Imaging
One experimental (CTC) and one standard (G-PERT) scan, at least 48 hours apart, before thyroid surgery. The order of the scans will be randomized.
After injection of CTC, a whole body and thyroid scan will be performed.
Other Name: Cyclotron-produced technetium
After injection of G-PERT, a whole body and thyroid scan will be performed.
Other Name: Generator-produced technetium
- Clinical Comparability of CTC with G-PERT [ Time Frame: up to 1 year ]
The primary efficacy endpoint is the clinical comparability of CTC with G-PERT consisting of a combination of the following results:
- A thyroid image, assessed for uptake or no uptake in the thyroid.
- A whole body biodistribution study, assessed for uptake or no uptake in selected anatomical areas.
- Change in vital signs after CTC injection [ Time Frame: Before CTC injection and after CTC scan (within ~30 min) ]Vital signs are measured before injection of CTC and after CTC scan and changes will be summarized.
- Changes in haematology / SMA-12 serum biochemistry after CTC injection [ Time Frame: Before CTC injection and after CTC scan (within ~30 min) ]A blood sample is drawn before injection of CTC and after CTC scan. The haematology and SMA-12 serum biochemistry parameters will be recorded and all changes will be summarized.
- Number of participants with adverse events [ Time Frame: up to 1 year ]Subjects will be monitored for adverse events after CTC and G-PERT scans while in the Nuclear Medicine Department. All adverse events observed or reported will be recorded and assessed.
- Correlation of CTC with other clinical findings [ Time Frame: up to 1 year ]Correlation of thyroid images with other clinical findings (such as pre-surgical ultrasound, FNA, and post-surgical pathology results, when available).
- CTC diagnostic outcomes and parameters [ Time Frame: up to 1 year ]Calculation of diagnostic outcomes (TP, TN, FP, FN) and the corresponding diagnostic parameters (sensitivity, specificity, accuracy).
- Overall clinical comparability of CTC with G-PERT [ Time Frame: up to 1 year ]The overall clinical comparability of CTC with G-PERT using diagnostic outcomes (True Positive, True Negative, False Positive, False Negative) to determine the corresponding diagnostic parameters (sensitivity, specificity, accuracy).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02980679
|Contact: Lai Schrader||780-432-8464||Lai.Schrader@ahs.ca|
|Contact: Marguerite Wieler, BScPT, PhD||780-391-7634||Marguerite.Wieler@ahs.ca|
|Cross Cancer Institute||Recruiting|
|Edmonton, Alberta, Canada, T6G 1Z2|
|Sub-Investigator: Todd McMullen, MD, PhD, FRCSC, FACS|
|Sub-Investigator: Marguerite Wieler, BScPT, PhD|
|Sub-Investigator: Terence Riauka, PhD|
|Principal Investigator:||Alexander (Sandy) JB McEwan, MB, FRCPC||Professor, Department of Oncology|