A Blinded Study Evaluating the Accuracy and Safety of Cyclotron-produced 99mTc in Adult Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 3
- 主要终点
- Agreement rate of the blinded read of scintiscans between cyclotronproduced 99mTc (CP) and the standard of care (SOC) in the diagnosis of hyperthyroidism
研究概览
简要总结
The purpose of this study is to evaluate technetium-99m (99mTc) pertechnetate produced by a cyclotron as a replacement for 99mTc pertechnetate obtained from a generator containing the parent isotope Molybdenum-99 (99Mo). 99mTc pertechnetate is currently used in nuclear medicine departments across the country. 99Mo is produced by a number of ageing nuclear reactors across the world and severe shortages of the isotope have occurred in the past few years. Cyclotron-produced 99mTc offers an alternative decentralized production method on a regional basis. Since the manufacturing process is different, the safety and efficacy of cyclotron-produced 99mTc pertechnetate must be evaluated in human subjects to enable its routine clinical use.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •WHO performance status 0-2
- •Older than the age of majority in the province where the study is performed, and be able to consent to the project
- •Ambulatory and able to lie supine for the duration of the examination.
- •Able and willing to return for a subsequent visit within 7 days to undergo a repeat examination and participate in a follow-up phone call to monitor for adverse events.
- •Subject referred for nuclear medicine examination for one of the following indications:
- •Biochemically documented hyperthyroidism, referred for scintigraphy to evaluate the differential diagnosis of hyperthyroidism or to plan radioiodine treatment.
- •Referred for bone scintigraphy for the evaluation of metastases, fractures, or inflammatory conditions. Subjects referred for a limited area (localized) bone scan are eligible, provided they agree to undergo a whole-body scan as part of the procedure.
排除标准
- •Pregnant, planning to become pregnant within 30 days
- •Severe evolving health problems (unstable coronary disease, liver failure, heart failure, end-stage-renal failure, hospitalized subjects with severe medical conditions) that may confound the assessment of adverse events.
- •For subjects evaluated for hyperthyroidism:
- •Recent iodine-containing IV contrast administration (< 6 weeks)
- •Recent amiodarone usage (< 8 weeks)
- •For subjects evaluated for bone scintigraphy:
- •Recent trauma occurring less than 24 hours prior to the first 99mTc bone scintigraphy examination, or between the first and second 99mTc bone scintigraphy examination.
- •Women who are breast-feeding are eligible to participate in this study, but must cease breast-feeding for 24 hours following the 99mTc examinations. They can draw their milk and discard it during this period, and use either formula or previously collected milk to feed their child.
研究组 & 干预措施
Evaluation of hyperthyroidism
For the evaluation of hyperthyroidism each research subject will undergo imaging using both cyclotron-produced 99mTc and the current standard method used at the site for thyroid imaging (either 123I or generator-produced 99mTc). Each study will be performed on a separate day, with flexibility to schedule either study first.
干预措施: Cyclotron-produced 99mTc (Drug)
Evaluation of hyperthyroidism
For the evaluation of hyperthyroidism each research subject will undergo imaging using both cyclotron-produced 99mTc and the current standard method used at the site for thyroid imaging (either 123I or generator-produced 99mTc). Each study will be performed on a separate day, with flexibility to schedule either study first.
干预措施: Generator-produced 99mTc (Drug)
Evaluation of altered osteogenesis by bone scintigraphy
For the evaluation of altered osteogenesis by bone scintigraphy each research subject will serve as his/her own control, and undergo imaging using both generator- and cyclotron-produced 99mTc. Each study will be performed on a separate day, with flexibility to schedule either study first.
干预措施: Cyclotron-produced 99mTc (Drug)
Evaluation of altered osteogenesis by bone scintigraphy
For the evaluation of altered osteogenesis by bone scintigraphy each research subject will serve as his/her own control, and undergo imaging using both generator- and cyclotron-produced 99mTc. Each study will be performed on a separate day, with flexibility to schedule either study first.
干预措施: Generator-produced 99mTc (Drug)
结局指标
主要结局
Agreement rate of the blinded read of scintiscans between cyclotronproduced 99mTc (CP) and the standard of care (SOC) in the diagnosis of hyperthyroidism
时间窗: 12 weeks
The result of the standard of care test and cyclotron-produced 99mTc pertechnetate will be compiled in a 2 x 2 table, and the corresponding proportions will be compared. The accuracy of the thyroid examinations will be compared to a clinical standard of care consisting of a combination of physical examination, laboratory testing, ultrasound evaluation (when available) and short-term clinical follow-up at 12 weeks. The accuracy of cyclotron-produced 99mTc will be compared to the accuracy of generator-produced 99mTc or 123I, using a non-inferiority test of correlated proportions.
次要结局
- Blinded subjective comparison of image quality between cyclotron- and generator-produced 99mTc using a 5-point Likert scale.(1 year)
- Number of participants with self-reported 99mTc-related adverse event.(24 hours)
- The target-to-background ratio(1 year)
- Number of participants with 99mTc-related adverse events as assessed by abnormal vital sign measurement.(1 hour)