Evaluation of Patients With Suspected Parathyroid Adenoma and Negative or Equivocal 99mTc Sestamibi SPECT/CT Using 18F Fluorocholine PET/CT
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Number of lesions detected by PET/CT for detecting parathyroid adenomas.
研究概览
简要总结
This study proposes the use of a well-established PET isotope, Fluorine-18 (18F), bound to Choline, for a prospective single-center, single-arm study for participants with suspected parathyroid adenoma and negative or equivocal standard of care 99mTc Sestamibi SPECT/CT
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •Suspected parathyroid adenoma (elevated serum calcium and inappropriately normal or high levels of parathyroid hormone)
- •Negative or equivocal 99mTc Sestamibi SPECT/CT
- •Able to provide written consent
- •Total bilirubin ≤ 1.5 x upper limit of normal (ULN)
- •Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤ 5 xULN
- •Karnofsky performance status of >50 (or ECOG/WHO equivalent)
- •Women must not be pregnant per the Department of Radiology Policy on Imaging in Potentially Pregnant and Pregnant Women.
排除标准
- •Less than 18 years old at the time of radiotracer administration
- •Creatinine clearance (calculated using Cockcroft-Gault formula, or measured) < 60 mL/min or serum creatinine >1.5 x ULN
- •QTcF >470 msec on electrocardiogram (ECG) or congenital long QT syndrome
研究组 & 干预措施
18FCH PET/CT
Participant receive 18F Fluorocholine injection and approximately 45-60 minutes later receive a low dose CT scan from skull base to mid thighs, followed by a static PET emission scan over the same area.
干预措施: 18Fluorocholine (Drug)
结局指标
主要结局
Number of lesions detected by PET/CT for detecting parathyroid adenomas.
时间窗: up to 1 hour
Inclusion criteria suggest recruiting patients with negative or equivocal SPECT/CT, so based on this there will be 0 lesions on SPECT/CT. The goal is to compare/count the number of lesions from PET/CT, if any present versus no lesions with SPECT/CT
次要结局
未报告次要终点
研究者
Andrei Iagaru
Professor of Radiology (Nuclear Medicine)
Stanford University