18F-Fluorocholine Positron Emission Tomography (PET) for the Detection of Parathyroid Adenomas
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- Thomas Hope
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Proportion of participants with true-positives (sensitivity) of 18F-Fluorocholine PET using sestamibi imaging
研究概览
简要总结
This is a prospective single arm single center Phase III study evaluating the ability of 18F-fluorocholine to detect the location of parathyroid adenomas.
详细描述
PRIMARY OBJECTIVE:
I. To investigate the performance (accuracy) of 18F-fluorocholine PET in the detection of hyperfunctioning parathyroid glands in surgical patients with biochemically proven primary hyperparathyroidism.
OUTLINE:
Participants will receive a single dose of 18F-Fluorocholine at the time the participant undergoes a single imaging study using 18F-fluorocholine. Study related procedures will end after the study visit. Participants who undergo subsequent parathyroidectomy, will have the results reviewed and compared to the results from the imaging study
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
- 13 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >= 13 years.
- •Biochemically proven hyperparathyroidism and an indication for surgery.
- •Ability to understand a written informed consent document, and the willingness to sign it.
排除标准
- •Current Pregnancy.
- •Patients unlikely to comply with study procedures, restrictions and requirements and judged by the Investigator to be unsuitable for study participation.
研究组 & 干预措施
Fluorocholine PET Imaging
Patients will undergo a single fluorocholine PET imaging study prior to surgery.
干预措施: 18F-Fluorocholine (Drug)
Fluorocholine PET Imaging
Patients will undergo a single fluorocholine PET imaging study prior to surgery.
干预措施: Positron emission tomography (PET) (Procedure)
结局指标
主要结局
Proportion of participants with true-positives (sensitivity) of 18F-Fluorocholine PET using sestamibi imaging
时间窗: Up to 1 year
Sensitivity of 18F-fluorocholine PET for the detection of abnormal parathyroid adenomas confirmed by pathology as compared to sestamibi imaging. Location of parathyroid adenoma at imaging as read by three blinded readers, will be correlated to the location at surgery. True positive will be defined as an adenoma on imaging in the same location as seen at surgery. Sensitivity will be reported by individual reader.
Proportion of participants with true-positives (sensitivity) of 18F-Fluorocholine PET using predefined threshold
时间窗: Up to 1 year
Sensitivity of 18F-fluorocholine PET for the detection of abnormal parathyroid adenomas confirmed by pathology compared to a predefined threshold. Location of parathyroid adenoma at imaging as read by three blinded readers, will be correlated to the location at surgery. True positive will be defined as an adenoma on imaging in the same location as seen at surgery. Sensitivity will be reported by individual reader.
次要结局
- Detection rate of 18F-fluorocholine PET(Up to 1 year)
研究者
Thomas Hope
Associate Professor
University of California, San Francisco