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

Thyroid Gland Diseases Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02980679
• Other study ID #: DX-CTC-003
• Secondary ID: HREBA.CC-16-0695
• Status: Completed
• Phase: Phase 3
• Start date: March 3, 2017
• Est. completion date: February 25, 2019

Study information

• Verified date: November 2018
• Source: University of Alberta
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: February 25, 2019
• Est. primary completion date: February 25, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 79 Years

Eligibility

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.

Related Conditions & MeSH terms

• Thyroid Diseases
• Thyroid Gland Diseases

Intervention

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

Locations

Country	Name	City	State
Canada	Cross Cancer Institute	Edmonton	Alberta

Sponsors (1)

Lead Sponsor	Collaborator
University of Alberta

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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
Secondary	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
Secondary	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
Secondary	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