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

NCT02980679 | Completed Phase 3

• 2 other identifiers: DX-CTC-003HREBA.CC-16-0695
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Thyroid Gland Diseases

Outcome Measures

Primary Outcomes (1)

• 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: 1. A thyroid image, assessed for uptake or no uptake in the thyroid. 2. A whole body biodistribution study, assessed for uptake or no uptake in selected anatomical areas.

  up to 1 year

Secondary Outcomes (6)

• Change in vital signs after CTC injection

  Before CTC injection and after CTC scan (within ~30 min)

• Changes in haematology / SMA-12 serum biochemistry after CTC injection

  Before CTC injection and after CTC scan (within ~30 min)

• Number of participants with adverse events

  up to 1 year

• Correlation of CTC with other clinical findings

  up to 1 year

• CTC diagnostic outcomes and parameters

  up to 1 year

Study Arms (1)

CTC and G-PERT Imaging

EXPERIMENTAL

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; Drug: G-PERT

Interventions

CTC DRUG

After injection of CTC, a whole body and thyroid scan will be performed.

Also known as: Cyclotron-produced technetium

CTC and G-PERT Imaging

G-PERT DRUG

After injection of G-PERT, a whole body and thyroid scan will be performed.

Also known as: Generator-produced technetium

CTC and G-PERT Imaging

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• \. Nursing or pregnant females.

Sponsors & Collaborators

• University of Alberta: lead

Study Sites (1)

Cross Cancer Institute

Edmonton, Alberta, T6G 1Z2, Canada

Location

MeSH Terms

Conditions

Thyroid Diseases

Condition Hierarchy (Ancestors)

Endocrine System Diseases

Study Officials

• Todd P McMullen, MD, PhD, FRCSC, FACS

  Associate Professor of Surgery and Oncology; Director, Division of Surgical Oncology, Department of Oncology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2016
• First Posted: December 2, 2016
• Study Start: March 3, 2017
• Primary Completion: February 25, 2019
• Study Completion: February 25, 2019
• Last Updated: April 11, 2022

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)