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前瞻性、盲法比较磁共振成像-超声融合与视觉评估在磁共振靶向前列腺活检中的应用:PROFUS 试验。

A prospective, blinded comparison of magnetic resonance (MR) imaging-ultrasound fusion and visual estimation in the performance of MR-targeted prostate biopsy: the PROFUS trial.

机构信息

Division of Urologic Oncology, Department of Urology, New York University Langone Medical Center, New York, NY, USA.

Department of Radiology, New York University Langone Medical Center, New York, NY, USA.

出版信息

Eur Urol. 2014 Aug;66(2):343-51. doi: 10.1016/j.eururo.2013.10.048. Epub 2013 Nov 8.

DOI:10.1016/j.eururo.2013.10.048
PMID:24262102
Abstract

BACKGROUND

Increasing evidence supports the use of magnetic resonance (MR)-targeted prostate biopsy. The optimal method for such biopsy remains undefined, however.

OBJECTIVE

To prospectively compare targeted biopsy outcomes between MR imaging (MRI)-ultrasound fusion and visual targeting.

DESIGN, SETTING, AND PARTICIPANTS: From June 2012 to March 2013, prospective targeted biopsy was performed in 125 consecutive men with suspicious regions identified on prebiopsy 3-T MRI consisting of T2-weighted, diffusion-weighted, and dynamic-contrast enhanced sequences.

INTERVENTION

Two MRI-ultrasound fusion targeted cores per target were performed by one operator using the ei-Nav|Artemis system. Targets were then blinded, and a second operator took two visually targeted cores and a 12-core biopsy.

OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS

Biopsy information yield was compared between targeting techniques and to 12-core biopsy. Results were analyzed using the McNemar test. Multivariate analysis was performed using binomial logistic regression.

RESULTS AND LIMITATIONS

Among 172 targets, fusion biopsy detected 55 (32.0%) cancers and 35 (20.3%) Gleason sum ≥7 cancers compared with 46 (26.7%) and 26 (15.1%), respectively, using visual targeting (p=0.1374, p=0.0523). Fusion biopsy provided informative nonbenign histology in 77 targets compared with 60 by visual (p=0.0104). Targeted biopsy detected 75.0% of all clinically significant cancers and 86.4% of Gleason sum ≥7 cancers detected on standard biopsy. On multivariate analysis, fusion performed best among smaller targets. The study is limited by lack of comparison with whole-gland specimens and sample size. Furthermore, cancer detection on visual targeting is likely higher than in community settings, where experience with this technique may be limited.

CONCLUSIONS

Fusion biopsy was more often histologically informative than visual targeting but did not increase cancer detection. A trend toward increased detection with fusion biopsy was observed across all study subsets, suggesting a need for a larger study size. Fusion targeting improved accuracy for smaller lesions. Its use may reduce the learning curve necessary for visual targeting and improve community adoption of MR-targeted biopsy.

摘要

背景

越来越多的证据支持使用磁共振(MR)靶向前列腺活检。然而,这种活检的最佳方法仍未确定。

目的

前瞻性比较 MRI-超声融合与视觉靶向靶向活检的结果。

设计、地点和参与者:2012 年 6 月至 2013 年 3 月,对 125 例可疑区域在术前 3-T MRI 上识别的连续男性患者进行前瞻性靶向活检,包括 T2 加权、扩散加权和动态对比增强序列。

干预措施

一名操作人员使用 ei-Nav|Artemis 系统对每个目标进行两次 MRI-超声融合靶向核心。然后对目标进行盲法,由第二名操作人员进行两次视觉靶向核心和 12 核活检。

测量和统计分析

比较两种靶向技术与 12 核活检的活检信息产量。结果使用 McNemar 检验进行分析。使用二项逻辑回归进行多变量分析。

结果和局限性

在 172 个目标中,融合活检检测到 55 例(32.0%)癌症和 35 例(20.3%)Gleason 总和≥7 癌症,而视觉靶向活检检测到 46 例(26.7%)和 26 例(15.1%)(p=0.1374,p=0.0523)。融合活检在 77 个目标中提供了有意义的非良性组织学信息,而视觉活检则为 60 个(p=0.0104)。靶向活检检测到标准活检中所有临床显著癌症的 75.0%和 Gleason 总和≥7 癌症的 86.4%。多变量分析显示,在较小的目标中,融合表现最佳。该研究的局限性在于缺乏与全腺标本的比较和样本量小。此外,视觉靶向检测到的癌症可能高于社区环境中的检测,在社区环境中,该技术的经验可能有限。

结论

融合活检在组织学上比视觉靶向更具信息量,但并未增加癌症检出率。融合活检在所有研究亚组中均观察到检测率增加的趋势,表明需要更大的研究规模。融合靶向检测提高了对较小病变的准确性。它的使用可能会减少视觉靶向所需的学习曲线,并提高社区对 MR 靶向活检的采用。

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