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High Resolution PET-MRI Before Prostate Cancer HIFU

2021年2月2日 更新者：Timothy J. Daskivich

High-Resolution, 18F-fluciclovine PET-MRI for Mapping Prostate Cancer in Patients Considering Focal High-Intensity Focused Ultrasound (HIFU) Therapy

This prospective trial aims to determine if enhanced prostate imaging using two novel imaging technologies (high resolution DWI and 18F-fluciclovine PET-MRI) will detect prostate cancers not seen on standard multiparametric prostate MRI in patients considered candidates for focal HIFU.

研究概览

地位

完全的

条件

干预/治疗

详细说明

This is a prospective trial to evaluate the effectiveness of 18F-fluciclovine PET-hrMRI versus standard mpMRI at identifying prostate cancer targets for HIFU therapy.

Participants with clinically localized, unilateral high grade prostate cancer (Gleason score 7-10 prostate cancer localized to one lobe on prior biopsies) OR at high risk for having unrecognized high grade prostate cancer (overall Gleason score 6 with > half of systematic biopsy cores positive and > 50% of core involvement in at least one core), interested in HIFU would receive both a standard mpMRI and 18F-fluciclovine PET-hrMRI.

Participants would then undergo a mapping biopsy using a standard sextant template plus MRI/US-fusion targeted biopsy of any lesion suspicious lesion on mpMRI or PET-hrMRI.

研究类型

介入性

注册 (实际的)

21

阶段

  • 阶段2

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 美国
    • California
      • Los Angeles、California、美国、90048
        • Cedars-Sinai Medical Center

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

男性

描述

Inclusion Criteria:

  • Prostate biopsy consisting of ≥ 10 tissue cores sampled
  • PSA </=20 ng/mL
  • cT1-cT2c
  • Either overall gleason score >/= 7 with Gleason grade 4 or 5 component localized to one lobe (i.e. right or left) OR overall Gleason score 6 with >/= half of systematic biopsy cores positive and >/= 50% of core involvement in at least one core
  • Patient considering focal HIFU therapy

Exclusion Criteria:

  • Previous local therapy for prostate cancer
  • Inability to receive PET tracer
  • Inability to receive MRI
  • Suggestion of extracapsular extension or seminal vesicle invasion on imaging
  • Estimated creatinine clearance <45 mL/min (Cockcroft-Gault equation)
  • Any other condition which, in the investigator's option, may make the patient a poor candidate for participation in a clinical trial.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：其他
  • 分配：不适用
  • 介入模型：单组作业
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：18F-Fluciclovine
10mCi +/-20% 18F-fluciclovine injection
药品：18F-Fluciclovine
Imaging (comparing standard and experimental high resolution diffusion-weighted imaging [DWI] MRI with 18F-Fluciclovine)
其他名称：
  • 阿舒明
  • prostate-cancer-specific radiotracer

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Number of Biopsy-proven Cancers (Gleason 6+) That Standard Imaging (mpMRI) Would Have Missed Compared With High Resolution Diffusion-weighted Imaging (DWI) PET-hrMRI on Mapping MRI.
大体时间：At time of post-imaging biopsy

A Gleason score of 6 is low grade, 7 is intermediate grade, and a score of 8 to 10 is high grade cancer. The Prostate Imaging Reporting and Data System (PI-RADS) is used to report how likely it is that a suspicious area is a clinically significant cancer. PI-RADS scores range from 1 (most likely not cancer) to 5 (very suspicious). Difference between sensitivities to identify prostate lesions. This is analyzed by the number of biopsy-proven cancerous zones (Gleason 6+) that mpMRI missed compared to PET or hrMRI (PIRADS) compared as follows:

mpMRI vs hrMRI and PET (PIRADS 3-5 & Gleason 7+) mpMRI vs hrMRI or PET (PIRADS 3-5 & Gleason 7+)

mpMRI vs hrMRI and PET (PIRADS 4-5 & Gleason 7+) mpMRI vs hrMRI or PET (PIRADS 4-5 & Gleason 7+)

mpMRI vs hrMRI and PET (PIRADS 3-5 & Gleason 6+) mpMRI vs hrMRI or PET (PIRADS 3-5 & Gleason 6+)

mpMRI vs hrMRI and PET (PIRADS 4-5 & Gleason 6+) mpMRI vs hrMRI or PET (PIRADS 4-5 & Gleason 6+)
At time of post-imaging biopsy
Number of Biopsy-proven Cancers (Gleason 7+) That Standard Imaging (mpMRI) Would Have Missed Compared With High Resolution Diffusion-weighted Imaging (DWI) PET-hrMRI on Mapping MRI.
大体时间：At time of post-imaging biopsy

A Gleason score of 6 is low grade, 7 is intermediate grade, and a score of 8 to 10 is high grade cancer. The Prostate Imaging Reporting and Data System (PI-RADS) is used to report how likely it is that a suspicious area is a clinically significant cancer. PI-RADS scores range from 1 (most likely not cancer) to 5 (very suspicious). Difference between sensitivities to identify prostate lesions. This is analyzed by the number of biopsy-proven cancerous zones (Gleason 7+) that mpMRI missed compared to PET or hrMRI (PIRADS) compared as follows:

mpMRI vs hrMRI and PET (PIRADS 3-5 & Gleason 7+) mpMRI vs hrMRI or PET (PIRADS 3-5 & Gleason 7+)

mpMRI vs hrMRI and PET (PIRADS 4-5 & Gleason 7+) mpMRI vs hrMRI or PET (PIRADS 4-5 & Gleason 7+)

mpMRI vs hrMRI and PET (PIRADS 3-5 & Gleason 6+) mpMRI vs hrMRI or PET (PIRADS 3-5 & Gleason 6+)

mpMRI vs hrMRI and PET (PIRADS 4-5 & Gleason 6+) mpMRI vs hrMRI or PET (PIRADS 4-5 & Gleason 6+)
At time of post-imaging biopsy

次要结果测量

结果测量
措施说明
大体时间
Negative Biopsy Rate (Number of Participants With Negative Biopsy)
大体时间：6 months following standard HIFU therapy
A Gleason score of 6 is low grade, 7 is intermediate grade, and a score of 8 to 10 is high grade cancer. The Prostate Imaging Reporting and Data System (PI-RADS) is used to report how likely it is that a suspicious area is a clinically significant cancer. PI-RADS scores range from 1 (most likely not cancer) to 5 (very suspicious). Following the tumor mapping study, patients with high grade disease (i.e. Gleason grade 4 or 5) in one lobe undergo hemigland or focal HIFU of that lobe. Patients would then undergo repeat prostate biopsy to assess the negative biopsy rate in the treated region.
6 months following standard HIFU therapy
Rate of High Grade Cancer (Number of Patients With High Grade Cancer)
大体时间：6 months following standard HIFU therapy
A Gleason score of 6 is low grade, 7 is intermediate grade, and a score of 8 to 10 is high grade cancer. The Prostate Imaging Reporting and Data System (PI-RADS) is used to report how likely it is that a suspicious area is a clinically significant cancer. PI-RADS scores range from 1 (most likely not cancer) to 5 (very suspicious). Following the tumor mapping study, patients with high grade disease (i.e. Gleason grade 4 or 5) in one lobe undergo hemigland or focal HIFU of that lobe. Patients would then undergo repeat prostate biopsy to assess the absence of Gleason grade 4 or 5 in the untreated region.
6 months following standard HIFU therapy

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Timothy J. Daskivich

合作者

Blue Earth Diagnostics

调查人员

  • 首席研究员：Timothy Daskivich, MD、Cedars-Sinai Medical Center

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2017年12月7日

初级完成 (实际的)

2020年1月8日

研究完成 (实际的)

2020年1月8日

研究注册日期

首次提交

2017年8月22日

首先提交符合 QC 标准的

2017年8月22日

首次发布 (实际的)

2017年8月28日

研究记录更新

最后更新发布 (实际的)

2021年2月21日

上次提交的符合 QC 标准的更新

2021年2月2日

最后验证

2021年2月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • IIT2016-19-DASKIVICH-18F

药物和器械信息、研究文件

研究美国 FDA 监管的药品

是的

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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