Comparison of 3 Tesla MRI to 7 Tesla MRI for Evaluation of Prostate Suspicion Lesions
2026年5月17日 更新者：Assaf-Harofeh Medical Center
A comparison of 3 Tesla MRI to 7 Tesla MRI for Evaluation of Prostate Suspicious Lesions.
Assess the added diagnostic value of ultra-high-field (7T) MRI over the current clinical standard (3T MRI) in detecting and characterizing suspicious prostate lesions. Evaluate whether dynamic deuterated glucose-enhanced imaging at 7T can offer improved contrast without the use of gadolinium-based agents.
研究概览
详细说明
Multiparametric MRI (mpMRI) at 3 Tesla is the current standard of care for the evaluation of prostate cancer, but its diagnostic accuracy is limited by false positives, particularly in the transition zone.
This leads to unnecessary biopsies and potential overtreatment.
Ultra-high-field 7 Tesla (7T) MRI offers higher signal-to-noise ratio, superior spatial and spectral resolution, and the ability to implement advanced imaging techniques without the need for endorectal coils.
In addition, dynamic glucose-enhanced MRI at 7T provides a promising alternative to gadolinium-based contrast agents, which are associated with safety concerns.
研究类型
介入性
注册 (估计的)
200
阶段
- 不适用
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。
学习联系方式
- 姓名：Shai Efrati, MD
- 电话号码：972549212866
- 邮箱：efratishai@outlook.com
学习地点
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Israel
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Zrifin、Israel、以色列、70300
- The Sagol Center for Hyperbaric Medicine and Research Shamir Medical Center (Assaf Harofeh)
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接触：
- Shai Efrati, Prof
- 电话号码：+972-8-9779393
- 邮箱：efratishai@outlook.com
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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
- 成人
- 年长者
接受健康志愿者
是的
描述
Inclusion Criteria:
- male patients referred for clinical 3T prostate MRI at Shamir Medical Center
- male patients who consent to undergo an additional 7T scan at the Weizmann Institute.
Exclusion Criteria:
- Contraindications to MRI (e.g., non-compatible implants, pacemakers, severe claustrophobia)
- diabetes mellitus
- glucose intolerance
- hyperglycemia
- hyperlactatemia
- chronic kidney disease (GFR <45 mL/min/1.73 m2).
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：诊断
- 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 |
|---|---|
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实验性的：3 Tesla (3T) versus 7 Tesla (7T) MRI in the assessment of suspicious prostate lesions
Each participant serves as their own control, undergoing both 3T and 7T MRI scans.
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Imaging protocols will include multiparametric sequences at both field strengths, with the addition of high-resolution anatomical and optional dynamic glucose-enhanced imaging at 7T.
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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 |
|---|---|---|
|
ROC analysis of diagnostic performance: 3T versus 7T MRI
大体时间：Assessed at the time of MRI acquisition during the study imaging visit.
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ROC analysis (Receiver Operating Characteristic analysis) - A statistical method used to evaluate and compare diagnostic accuracy.
It examines how well a test distinguishes between diseased and non-diseased cases across different thresholds.
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Assessed at the time of MRI acquisition during the study imaging visit.
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Sensitivity and Specificity of diagnostic performance: 3T versus 7T MRI
大体时间：Assessed at the time of MRI acquisition during the study imaging visit.
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Sensitivity - The ability of the MRI to correctly identify patients who truly have disease (true positive rate). High sensitivity means fewer missed cases. Specificity - The ability of the MRI to correctly identify patients who do not have disease (true negative rate). High specificity means fewer false alarms or false positives. |
Assessed at the time of MRI acquisition during the study imaging visit.
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Lesion conspicuity of diagnostic performance: 3T versus 7T MRI
大体时间：Assessed at the time of MRI acquisition during the study imaging visit.
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How clearly and visibly an abnormal lesion can be seen on MRI images compared with surrounding tissue.
Higher conspicuity generally makes lesions easier to detect and characterize.
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Assessed at the time of MRI acquisition during the study imaging visit.
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PI-RADS classification - The Prostate Imaging Reporting and Data System: 3T versus 7T MRI
大体时间：Assessed at the time of MRI acquisition during the study imaging visit.
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a standardized scoring system used in prostate MRI to estimate the likelihood of clinically significant prostate cancer.
Scores range from 1 (very low likelihood) to 5 (very high likelihood).
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Assessed at the time of MRI acquisition during the study imaging visit.
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Quantitative imaging metrics of diagnostic performance: 3T versus 7T MRI
大体时间：Assessed at the time of MRI acquisition during the study imaging visit.
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Numerical measurements derived from MRI images, such as lesion size, signal intensity, contrast ratios, diffusion values (e.g., ADC), or texture features, used to objectively compare imaging performance.
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Assessed at the time of MRI acquisition during the study imaging visit.
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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。
调查人员
- 首席研究员：Shai Efrati、Asaf-Harofhe MC
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 (估计的)
2027年1月1日
初级完成 (估计的)
2030年1月1日
研究完成 (估计的)
2030年1月1日
研究注册日期
首次提交
2026年4月16日
首先提交符合 QC 标准的
2026年5月17日
首次发布 (实际的)
2026年5月22日
研究记录更新
最后更新发布 (实际的)
2026年5月22日
上次提交的符合 QC 标准的更新
2026年5月17日
最后验证
2026年2月1日
更多信息
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.