NCT04040946已完成3 期
Phase III Trial Comparing 2 Diagnostic Strategies for Preoperative Localization of Parathyroid Adenoma in Primary Hyperparathyroidism:TEMP / CT With Tc99m-sestaMIBI or PET / CT With F18-choline in First Intention
Centre Francois Baclesse5 个研究点 分布在 1 个国家目标入组 59 人开始时间: 2019年9月19日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 59
- 试验地点
- 5
- 主要终点
- Compare, between each diagnostic strategy, the proportion of patients for whom the first-line imaging technique guided the surgical procedure wisely
研究概览
简要总结
The investigators hypothesize that positron emission tomography with fluorocholline (F18-choline PET) will reduce the proportion of unnecessary invasive surgery decisions and that the higher cost of positron emission tomography versus MIBI scintigraphy (Tc99m-sestaMIBI ) will be offset by lower cost in terms of type. surgery performed wisely and complications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient 18 years old
- •Patient presenting with primary hyperparathyroidism and for whom an excisional surgery is planned
- •For women of childbearing age, negative pregnancy test at Baseline
- •Biological assessment confirming the diagnosis of primary hyperparathyroidism (high serum PTH and calcium concentrations)
- •Affiliation to a social security scheme
- •Patient having signed his written consent
排除标准
- •Patient deprived of liberty, under tutorship or curatorship
- •Hypersensitivity to TECNESCAN SESTAMIBI
- •Any associated medical or psychological condition that could compromise the patient's ability to participate in the study
- •Pregnant or lactating woman
- •History of parathyroid surgery
- •Patient with multiple endocrine neoplasia 1 (NEM1)
- •Known hypersensitivity to fluorocholine or to any of the excipients (sodium chloride, water for injections)
结局指标
主要结局
Compare, between each diagnostic strategy, the proportion of patients for whom the first-line imaging technique guided the surgical procedure wisely
时间窗: Up to 2 months
次要结局
- Evaluate post-surgical complications by measuring tne number of infections, hematoma(Up to 2 months)
- Estimate the diagnostic performance of each strategy by measuring sensitivity and specificity(Up to 2 months)
研究者
研究点 (5)
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