Clinical trial NCT02980679: 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Thyroid Gland Diseases
Lead sponsor: University of Alberta
Sponsor class: OTHER
First posted: 2016-12-02
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Clinical Comparability of CTC with G-PERT
timeFrame: up to 1 year
Secondary outcomes:
measure: Change in vital signs after CTC injection
timeFrame: Before CTC injection and after CTC scan (within ~30 min)
measure: Changes in haematology / SMA-12 serum biochemistry after CTC injection
timeFrame: Before CTC injection and after CTC scan (within ~30 min)
measure: Number of participants with adverse events
timeFrame: up to 1 year
measure: Correlation of CTC with other clinical findings
timeFrame: up to 1 year
measure: CTC diagnostic outcomes and parameters
timeFrame: up to 1 year
measure: Overall clinical comparability of CTC with G-PERT
timeFrame: up to 1 year
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: Cross Cancer Institute
state: Alberta
Study officials:
affiliation: Associate Professor of Surgery and Oncology; Director, Division of Surgical Oncology, Department of Oncology
name: Todd P McMullen, MD, PhD, FRCSC, FACS
role: PRINCIPAL_INVESTIGATOR
References: