A Prospective Study of Hybrid PET/MRI in the Evaluation of Men With Suspected Prostate Cancer Recurrence Following Definitive Local Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- Frequency in change of clinical management based on results of 18F-FCH PET/MRI
研究概览
简要总结
Evaluate the impact of hybrid 18F-Fluoro-choline (18F-FCH) PET/MRI imaging on the clinical management of men with suspected recurrent prostate cancer post prostatectomy or radiotherapy.
We hypothesize that hybrid imaging incorporating 18F-FCH PET/MRI imaging will be feasible and will lead to changes in management decisions among men being re-staged for suspected prostate cancer recurrence post-surgery or radiation who are potentially eligible for local salvage therapy.
详细描述
The study will be a non-randomized, prospective study of men with suspected local recurrence of prostate cancer post-prostatectomy or radiation with negative bone and CT scans. Hybrid PET/MRI using 18F-FCH will be obtained and a consensus staging report generated for the attending clinician. Clinical management questionnaires completed by the study investigator will be obtained pre and post imaging in order to gauge the impact of the hybrid imaging on clinical decision making.
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
- 19 Years 至 100 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Prostate cancer with rising prostate specific antigen (PSA) post prostatectomy or radiotherapy
- •Suspected recurrence based on PSA rise measured on 3 occasions at least 3 months apart and an absolute PSA > 0.2 ng/mL
- •Bone scan and CT scan of the abdomen and pelvis negative for metastatic disease
排除标准
- •Evidence of metastatic disease
- •Contradiction to 18F-FCH PET scan
- •Contraindication to MRI
研究组 & 干预措施
18F-FCH PET/MRI imaging
Patients eligible for the study will have an 18F-FCH PET/MRI in addition to standard of care clinical assessment and imaging (CT and bone scan)
干预措施: 18F-FCH PET/MRI imaging (Other)
结局指标
主要结局
Frequency in change of clinical management based on results of 18F-FCH PET/MRI
时间窗: Within 2 weeks of study scan
A questionnaire to assess the planned management will be completed by the investigator before and after provision of the results of the 18F-FCH PET/MRI to determine if the information provided by 18F-FCH PET/MRI influences the preferred plan of management
次要结局
- Number of lesions identified with 18F-FCH based on consensus reporting(Within 2 weeks of study scan)