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

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

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.

Study Overview

• Status: Completed
• Conditions: Thyroid Gland Diseases
• Intervention / Treatment: Drug: CTC; Drug: G-PERT

Detailed Description

The clinical trial will be a Phase III, prospective, crossover, image interpretation blinded, single site study. All subjects will receive Tc-99m pertechnetate (one CTC and one G-PERT administration separated by at least 48 hours) and subsequently be imaged for thyroid uptake and whole body biodistribution. The order of the scans will be randomized. The thyroid image will be interpreted for uptake / no uptake in the thyroid, and the whole body biodistribution image will be interpreted for uptake / no uptake in selected anatomical sites. Interpretation of thyroid imaging results will be compared with other clinical findings (such as pre-surgical ultrasound, fine needle aspirate, and post-surgical pathology results, when available). All imaging assessments will be conducted by 1 blinded Nuclear Medicine physician. A safety evaluation will be conducted on all subjects receiving CTC, consisting of vital signs, haematology and SMA-12 serum biochemistry profile (pre-injection and post-imaging), and, for both CTC and G-PERT, an adverse event assessment (until the subject leaves the Nuclear Medicine department) after each administration.

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Phase 3

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:

1. Male or female ≥ 18 years of age and < 80 years of age.
2. Have a proven or suspected thyroid pathology that requires surgery by standard clinical criteria.
3. Able and willing to follow instructions and comply with the protocol.
4. Provide written informed consent prior to participation in the study.

Exclusion Criteria:

1. Nursing or pregnant females.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Drug: CTC; After injection of CTC, a whole body and thyroid scan will be performed.; Other Names: Cyclotron-produced technetium; Drug: G-PERT; After injection of G-PERT, a whole body and thyroid scan will be performed.; Other Names: Generator-produced technetium

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Comparability of CTC with G-PERT	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.	up to 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in vital signs after CTC injection	Vital signs are measured before injection of CTC and after CTC scan and changes will be summarized.	Before CTC injection and after CTC scan (within ~30 min)
Changes in haematology / SMA-12 serum biochemistry after CTC injection	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.	Before CTC injection and after CTC scan (within ~30 min)
Number of participants with adverse events	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.	up to 1 year
Correlation of CTC with other clinical findings	Correlation of thyroid images with other clinical findings (such as pre-surgical ultrasound, FNA, and post-surgical pathology results, when available).	up to 1 year
CTC diagnostic outcomes and parameters	Calculation of diagnostic outcomes (TP, TN, FP, FN) and the corresponding diagnostic parameters (sensitivity, specificity, accuracy).	up to 1 year
Overall clinical comparability of CTC with G-PERT	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).	up to 1 year

Collaborators and Investigators

• Sponsor: University of Alberta
• Investigators: Principal Investigator: Todd P McMullen, MD, PhD, FRCSC, FACS, Associate Professor of Surgery and Oncology; Director, Division of Surgical Oncology, Department of Oncology

Study record dates

Study Major Dates

• Study Start (Actual): March 3, 2017
• Primary Completion (Actual): February 25, 2019
• Study Completion (Actual): February 25, 2019

Study Registration Dates

• First Submitted: November 22, 2016
• First Submitted That Met QC Criteria: November 29, 2016
• First Posted (Estimate): December 2, 2016

Study Record Updates

• Last Update Posted (Actual): April 11, 2022
• Last Update Submitted That Met QC Criteria: April 1, 2022
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Thyroid Diseases
• Other Study ID Numbers: DX-CTC-003; HREBA.CC-16-0695 (Other Identifier: Health Research Ethics Board of Alberta Cancer Committee)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No