NCT03324893已完成不适用
18F-Fluorocholine PET/MRI for the Localization of Parathyroid Adenomas
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 47
- 试验地点
- 2
- 主要终点
- Accuracy of [F-18]-FCH PET/MRI in localization of diseased parathyroid gland
研究概览
简要总结
A prospective trial comparing the accuracy of [F-18]-FCH PET/MRI to US and 99mTc-MIBI SPECT/CT for pre-operative parathyroid localization in patients with primary hyperparathyroidism
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 ≥ 18 years
- •Biochemically proven primary hyperparathyroidism
- •Indication for parathyroidectomy as per institutional guidelines
排除标准
- •Contraindication for MRI as per current institutional guidelines.
- •Contraindication for Gadolinium injection as per current institutional guidelines.
- •Renal failure
- •Inability to lie supine for at least 45 minutes.
- •Any participant who is pregnant or breastfeeding.
- •Participants receiving erythropoietin (i.e. for hemochromatosis; might lead to false negative results due to stimulation of bone marrow metabolism)
- •Familial HPT syndromes
- •Participant currently being treated with any cytotoxic chemotherapy
结局指标
主要结局
Accuracy of [F-18]-FCH PET/MRI in localization of diseased parathyroid gland
时间窗: 1 month postoperatively
Value of \[F-18\]-FCH PET/MRI next to Ultrasound of the Neck and 99mTc-MIBI SPECT/CT in determining which of the four parathyroid glands Reference standards: * Intra-operative location of the hyper functioning gland by inspection and post-operative pathological confirmation. * Determination of biochemical cure per usual standard of care: intraoperative PTH and calcium and PTH postoperatively.
次要结局
未报告次要终点
研究者
研究点 (2)
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