ACTRN12621001674820已完成未知
18F-DCPYL-PET for diagnosis of primary prostate cancer in men with positive mpMRI and negative biopsy
St Vincent's Hospital Melbourne0 个研究点目标入组 29 人开始时间: 2021年12月7日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 29
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Diagnosis
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- Male
入选标准
- •High clinical suspicion for prostate cancer (within 12mo) based on the following criteria:
- •positive mpMRI suggesting presence of prostate cancer, but who have had a negative prostate biopsy.
- •Prostate-Specific Antigen (PSA) >10 or
- •PSA density > 0.15 or
- •Palpable abnormality on Digital Rectal Exam (DRE) or
- •MRI lesion PIRADS greater than or equal to 4 and size >5mm
- •men with greater than or equal to 1 negative prostate biopsy, undertaken via any of the following techniques:
- •-cognitive fusion transrectal
- •-cognitive fusion transperineal
- •-software fusion transperineal
- •Age 18 years and above
- •Patient has provided written informed consent for participation in this trial
- •In the opinion of investigator, willing and able to comply with required study procedures
排除标准
- •Patients who have developed interval contra-indication to have mpMRI prostate:
- •MRI incompatible implants or metal fragments
- •claustrophobia
- •unable to have intravenous gadolinium
- •unable to fit in the MRI due to BMI
- •Significant inter-current morbidity that, in the judgment of the investigator, would limit compliance with study protocols
研究者
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