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 Baclesse4 个研究点分布在 1 个国家目标入组 59 人2019年9月19日

适应症Parathyroid Adenoma Hyperparathyroidism F18-choline

概览

阶段: 3 期
干预措施: 未指定
疾病 / 适应症: Parathyroid Adenoma
发起方: Centre Francois Baclesse
入组人数: 59
试验地点: 4
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
状态: 已完成
最后更新: 2年前

概览研究者入排标准结局指标研究点相似试验

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.

注册库

clinicaltrials.gov

开始日期

2019年9月19日

结束日期

2023年6月30日

最后更新

2年前

研究类型

Interventional

研究设计

Parallel

性别

All

研究者

发起方

Centre Francois Baclesse

责任方

Sponsor

入排标准

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)