A Pilot Study of 68Ga PSMA 11 PET/MRI and 68Ga RM2 PET/MRI for Biopsy Guidance in Patients With Suspected Prostate Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Number of Participants With Biopsy Results Correlated With PET Based Imaging Findings
研究概览
简要总结
The objective of the study is to evaluate 68Ga PSMA 11 PET/MRI and 68Ga RM2 PET/MRI for biopsy guidance in patients with suspected prostate cancer.
详细描述
Primary Objective: To evaluate 68Ga PSMA 11 PET/MRI and 68Ga RM2 PET/MRI for biopsy guidance in patients with suspected prostate cancer.
Exploratory Objective:
- Correlation of 68Ga PSMA 11 uptake and Gleason score at biopsy
- Correlation of 68Ga RM2 and Gleason score at biopsy
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Diagnostic
- 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 prostate cancer
- •Planned prostate biopsy
- •Able to provide written consent
- •Karnofsky performance status of 50 (or ECOG/WHO equivalent)
排除标准
- •Patients not capable of getting PET study due to weight, claustrophobia, or inability to lay still for the duration of the exam
- •Metallic implants (contraindicated for MRI)
研究组 & 干预措施
68Ga PSMA11 first followed by 68Ga RM2
Participant will be injected IV with 3 to 7 mCi of 68Ga PSMA11 and then within two weeks Participant will be injected IV with 140 ±20% mBq of 68Ga RM2
干预措施: 68Ga-PSMA-11 (Drug)
68Ga RM2 first followed by 68Ga PSMA11
Participant will be injected IV with 140 ±20% mBq of 68Ga RM2 and then within two weeks Participant will be injected IV with 3 to 7 mCi of 68Ga PSMA11
干预措施: 68Ga RM2 (Drug)
68Ga RM2 first followed by 68Ga PSMA11
Participant will be injected IV with 140 ±20% mBq of 68Ga RM2 and then within two weeks Participant will be injected IV with 3 to 7 mCi of 68Ga PSMA11
干预措施: 68Ga-PSMA-11 (Drug)
68Ga RM2 first followed by 68Ga PSMA11
Participant will be injected IV with 140 ±20% mBq of 68Ga RM2 and then within two weeks Participant will be injected IV with 3 to 7 mCi of 68Ga PSMA11
干预措施: Investigational PET scanner coils and software (Device)
68Ga PSMA11 first followed by 68Ga RM2
Participant will be injected IV with 3 to 7 mCi of 68Ga PSMA11 and then within two weeks Participant will be injected IV with 140 ±20% mBq of 68Ga RM2
干预措施: 68Ga RM2 (Drug)
68Ga PSMA11 first followed by 68Ga RM2
Participant will be injected IV with 3 to 7 mCi of 68Ga PSMA11 and then within two weeks Participant will be injected IV with 140 ±20% mBq of 68Ga RM2
干预措施: Investigational PET scanner coils and software (Device)
结局指标
主要结局
Number of Participants With Biopsy Results Correlated With PET Based Imaging Findings
时间窗: Up to approximately 2 hours to complete each scan
Measure of PET based Biopsy Guidance (ie, prostate uptake on 68Ga PSMA 11 and 68Ga RM2 scans).
次要结局
未报告次要终点
研究者
Andrei Iagaru
Professor of Radiology (Nuclear Medicine)
Stanford University