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
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Clinical Comparability of CTC with G-PERT
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Nursing or pregnant females.
研究组 & 干预措施
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.
干预措施: CTC (Drug)
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.
干预措施: G-PERT (Drug)
结局指标
主要结局
Clinical Comparability of CTC with G-PERT
时间窗: 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: 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.
次要结局
- Correlation of CTC with other clinical findings(up to 1 year)
- Changes in haematology / SMA-12 serum biochemistry after CTC injection(Before CTC injection and after CTC scan (within ~30 min))
- CTC diagnostic outcomes and parameters(up to 1 year)
- Change in vital signs after CTC injection(Before CTC injection and after CTC scan (within ~30 min))
- Number of participants with adverse events(up to 1 year)
- Overall clinical comparability of CTC with G-PERT(up to 1 year)