Diagnostic Value of 18F-fluorocholine PET/CT Imaging in Localization of Hyperfunctioning Parathyroid Tissue in Hyperparathyroidism
试验速览
- 阶段
- 不适用
- 入组人数
- 1,000
- 试验地点
- 2
- 主要终点
- Sensitivity & Specificity
研究概览
简要总结
To assess the efficiency of 18F-fluorocholine PET/CT in localization of hyperfunctioning parathyroid tissue in hyperparathyroidism, thereby enabling minimally invasive surgical approaches with fewer complications and comparable success rates
详细描述
Primary hyperparathyroidism is a common endocrine disorder for which the diagnosis is biochemical and therapy surgical in the vast majority of cases; in secondary and tertiary hyperparathyroidism, surgical treatment is usually chosen when conservative measures fail to control the condition. The previously used surgical approach of bilateral neck exploration is being replaced by minimally invasive procedures, whose advantage is shorter duration of operation and general anesthesia, lower morbidity and fewer complications with comparable success rates.
A prerequisite for minimally invasive surgery is successful localization of the offending parathyroid tissue. Most commonly used imaging modality for this purpose is parathyroid scintigraphy with 99mTc-sestaMIBI, usually supplemented by ultrasound of the neck. Overall, parathyroid scintigraphy is a sensitive method for localization of hyperfunctioning parathyroid tissue; however, its diagnostic performance is significantly lower in patients with multiple parathyroid lesions.
In comparison to conventional nuclear medicine imaging approaches for localization of the offending parathyroid tissue, positron emission tomography with computed tomography (PET/CT) offers superior image resolution with an additional advantage of attenuation correction and co-registration of functional and anatomical information. 18F-fluorocholine is a PET tracer which is commonly used for prostate cancer imaging. In contrast to 18F-fluorodeoxyglucose (18F-FDG), it is also taken up by well-differentiated neoplasms in which 18F-FDG uptake is unreliable. The investigators hypothesize that 18F-fluorocholine might be efficiently taken up by parathyroid adenomata and/or hyperplasia.
The aim of this study is to investigate the efficiency of localization of hyperfunctioning parathyroid tissue with 18F-fluorocholine PET/CT in patients with primary hyperparathyroidism and to compare its efficiency to conventional scintigraphic imaging methods for this purpose.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age over 18 years
- •Biochemically proven hyperparathyroidism (elevated iPTH, elevated on normal Ca2+) or elevated Ca2+ and inadequately supressed iPTH
排除标准
- •Age under 18 years
- •Pregnancy
- •Clinical history of oncological, inflammatory/infectious disease of the head and neck
结局指标
主要结局
Sensitivity & Specificity
时间窗: 3 months
Ability to detect the hyperfunctioning parathyroid tissue
次要结局
- Improvement in patient management - operating time(3 years)
- Biochemical/clinical outcome - Ca2+ levels(1 year)
- Biochemical/clinical outcome - iPTH levels(1 year)
- Improvement in patient management - cost(3 years)
- Improvement in patient management - complications of surgery(3 years)
- Improvement in patient management - duration of hospital stay(3 years)
研究者
Luka Lezaic MD PhD
MD PhD
University Medical Centre Ljubljana