Localization of Parathyroid Adenoma by Fluorocholine Positron Emission Tomography/MRI (PET/MRI): A Prospective Pilot Study
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Adenomas size and location
研究概览
简要总结
A comparative prospective study to evaluate different imaging modalities (pet-ct and pet-mr) prior to surgery in parathyroid tumor patients.
详细描述
Patients with Hyperthyroidism and surgery indication will be recruited and directed to imagine exams. in addition to the conservative 99mTc-MIBI (methoxyisobutylisonitrile) and US, patients will also undergo 18FCH (¹⁸F-choline) PET/MRI for detecting adenomas and their location. imaging experts will decode the imaging exams. sensitivity and specificity of the exams will be examined.
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
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who meet the criteria accepted in the World Health Organization (WHO) analysis:
- •Symptomatic patients (constipation, depression, peptic ulcer, pathologic fractures, chronic fatigue, pain from a urinary tract stones etc..)
- •or at least one of the following criteria:
- •Blood calcium levels above 1 more than normal
- •Creatinine clearance decreased in 30% from age expected
- •Urine Creatinine above 400 mg in 24 hours
排除标准
- •Patients with hyperthyroidism secondary and tertiary (secondary to kidney disease)
- •Patients who are not eligible to sign an informed consent
- •Pregnant women
- •Patients with sensitivity (allergy) technetium or 18FCH
研究组 & 干预措施
Control Group
primary hyperthyroidism patients that will be refered to the routine exams (PET-CT)
干预措施: PET-CT (Device)
Study group
primary hyperthyroidism patients that will be refered to the routine exams (PET-CT) and in addition will also undergo the PET-MR
干预措施: PET-MR (Device)
Study group
primary hyperthyroidism patients that will be refered to the routine exams (PET-CT) and in addition will also undergo the PET-MR
干预措施: PET-CT (Device)
结局指标
主要结局
Adenomas size and location
时间窗: 24 months
Location of adenomas by a report analyzing the pathological examination (PET-CT/PET-MR output).
次要结局
- Parathyroid hormone levels(24 months)
- Disease related medication consumption(24 months)
- Chronic disease duration(24 months)