18F-Fluorocholine for the Detection of Parathyroid Adenomas
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Thomas Hope
- 入组人数
- 98
- 试验地点
- 1
- 主要终点
- Proportion of True Positives for the Detection of the Abnormal Parathyroid Adenoma Using Sestamibi Imaging
研究概览
简要总结
The investigators are studying the ability of F18 labeled fluorocholine PET to localize parathyroid adenomas in patients with hyperparathyroidism prior to surgery.
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
- •Biochemically proven hyperparathyroidism and an indication for surgery
- •Age >= 13 years old
- •Karnofsky performance status of > 50 (or Eastern Cooperative Oncology Group (ECOG)/World Health Organization (WHO) equivalent).
- •Ability to understand a written informed consent document, and the willingness to sign it.
排除标准
- •Patients exceeding the weight limitations of the scanner or are not able to enter the bore of the PET scanner due to BMI.
- •Inability to lie still for the entire imaging time (e.g. cough, severe arthritis, etc.).
- •Inability to complete the needed investigational due to other reasons (severe claustrophobia, radiation phobia, etc.).
- •Pregnancy.
研究组 & 干预措施
18F-Fluorocholine PET
Patients will undergo a single fluorocholine PET imaging study prior to surgery.
干预措施: 18F-Fluorocholine (Drug)
18F-Fluorocholine PET
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 True Positives for the Detection of the Abnormal Parathyroid Adenoma Using Sestamibi Imaging
时间窗: Up to 1 year
The true positive (sensitivity) rate is defined as the proportion of participants with location of the suspected adenoma on 18F-Fluorocholine PET correlating with location of an abnormal parathyroid at time of participant surgery. For a patient with multiple hyperplastic glands, only one gland needs to correlate for the patient to count as a true positive. In patients who had a sestamibi study performed prior to the fluorocholine imaging study, the original dictated report from the sestamibi will be used for comparison. For analysis, adenomas described as arising in the mid thyroid bed will considered correct if located in either the inferior or superior bed. Patients will be followed-up to determine if they undergo a parathyroidectomy for up to 1 year.
Proportion of True Positives for the Overall Detection of the Abnormal Parathyroid Adenoma
时间窗: Up to 1 year
The true positive (sensitivity) rate is defined as the proportion of participants with location of the suspected adenoma on 18F-Fluorocholine PET correlating with location of an abnormal parathyroid at time of participant surgery. For a patient with multiple hyperplastic glands, only one gland needs to correlate for the patient to count as a true positive. For analysis, adenomas described as arising in the mid thyroid bed will considered correct if located in either the inferior or superior bed. Patients will be followed-up to determine if they undergo a parathyroidectomy for up to 1 year.
次要结局
- Detection Rate in Patients Who Have Not Undergone Surgical Resection(Up to 1 year)
研究者
Thomas Hope
Associate Professor, Radiology
University of California, San Francisco