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临床试验/NCT07603908
NCT07603908尚未招募不适用

Comparison of 3 Tesla MRI to 7 Tesla MRI for Evaluation of Prostate Suspicion Lesions

Assaf-Harofeh Medical Center1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2027年1月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
200
试验地点
1

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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).

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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