Comparative Evaluation of Metastatic Lesions From Prostate Carcinoma With 18F-NaF and 18F-Fluorocholine PET/CT
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- The sensitivities of 18F-fluorocholine PET/CT and NaF PET/CT
研究概览
简要总结
Prostate cancer remains to be a public health problem around the world. For patients with prostate cancer, diphosphonate bone scintigraphy (BS) and pelvic tomographic imaging are major imaging tools to evaluate the disease spread. However, the conventional image modalities have only limited sensitivity and specificity. New imaging tracer with 18F-fluorocholine (18F-FCH) and old radiopharmaceuticals with NaF has showed promising results in detecting prostate cancers over bone scan. Nevertheless, the diagnostic performance of each tool has less been compared.
The goal of this study is to compare the diagnostic performance of 18F-FCH PET/CT and NaF PET/CT for prostate cancer patients.
The investigators prospectively enroll patients with the pathological diagnosis of prostate cancer and intended to receive radionuclide bone image. The patients will receive NaF PET/CT and 18F-FCH PET/CT. Each image will be evaluated by experienced interpreter for abnormal uptake suspicious for cancer spreading. The reference standard will be a combination of tissue correlation, imaging, laboratory and clinical data. Diagnostic performance of both PET/CT scans will be measured and calculated.
详细描述
The investigators conducted a prospective study to investigate the performance of 18F-choline (FCH) PET/CT and 18F-NaF PET in the patients with prostate adenocarcinoma.
18F-NaF PET imaging protocol: Fasting is not needed before radiotracer injection. No specific drug restriction is needed. Scan will be conduced by using a PET/CT unit (Discovery ST; GE Medical Systems, Milwaukee,Wis), and scans will be interpreted on a work station with the use of compatible software (Xeleris).
An indwelling intravenous catheter connected to an infusion line and an saline syringe will be set on each patient. 18F-NaF (148 +/- 10% MBq) will be injected intravenously through the infusion line and will be flushed by saline. NaF PET/CT scan acquisition is to be taken 30 minutes after radiotracer injection. The PET/CT (120 mA, 120 kVp) scan field will cover from vertex to toe.
Image analysis: Two nuclear medicine physicians assess the NaF PET/CT images. The investigators have access to the patients' history and interpreted individually by each reader, with disagreements to be resolved by consensus. Uptake in the focus will be evaluated of the likelihood of cancer in 5-graded scale. 0. No cancer or definitely no pathologic aspect; 1. Probably benign lesion; 2. Equivocal lesion; 3. Probably cancer; 4. Most probably cancer. For the determination of a diagnosis, score 0 and 1 are considered a negative result and 2 to 4 a positive result.
18F-FCH PET imaging protocol: The 18F-FCH PET will be arranged within 6 weeks after NaF PET. Fasting is not needed before radiotracer injection. No specific drug restriction is needed. Scan will be conduced by using a PET/CT unit (Discovery ST; GE Medical Systems, Milwaukee,Wis), and scans will be interpreted on a work station with the use of compatible software (Xeleris).
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patients are pathologically diagnosed with prostate adenocarcinoma.
- •Received NaF PET/CT.
排除标准
- •Diagnosed to have multiple cancers
- •Younger than 20-year-old
- •Known allergic to investigational drug
- •The patients is classified as not suited for the exam by the investigators.
研究组 & 干预措施
18F-fluorocholine PET/CT
18F-fluorocholine PET/CT
干预措施: 18F-fluorocholine (Drug)
结局指标
主要结局
The sensitivities of 18F-fluorocholine PET/CT and NaF PET/CT
时间窗: 6 weeks
The lesion-based sensitivities of these two image modalities (The number of true positive image findings/The number of confirmed metastasis)
The specificities of 18F-fluorocholine PET/CT and NaF PET/CT
时间窗: 6 weeks
The lesion-based specificities of these two image modalities (The number of true negative image findings/The number of confirmed e benign lesion)
次要结局
- Extraskeletal metastatic lesions detected by 18F-fluorocholine PET/CT(6 weeks)