Comparing Prostate Cancer Screening Between Standardized 3T MRI Screening Protocol and Low-Field MRI in a Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- Evaluate the diagnostic accuracy of 0.55T MRI in detecting prostate suspicious lesions using the PI-RADS grading score, with the results of as the reference standard.
研究概览
简要总结
This study compares the effectiveness of low-field MRI (0.55T) with high-field MRI (3T) in prostate cancer screening and image quality. It consists of three phases: optimizing the low-field MRI protocol with healthy volunteers, evaluating image quality in patients with metallic artifacts (like hip prostheses), and assessing low-field MRI in patients with suspicious prostate lesions found on high-field MRI.
详细描述
This study aims to compare the effectiveness of low-field MRI (0.55T) with traditional high-field MRI (3T) in prostate cancer screening and image quality improvement. The study is conducted in three phases: first, a pilot study with healthy volunteers to optimize the low-field MRI protocol; second, an evaluation of image quality between the two types of MRI in patients with metallic artifacts, particularly due to hip prostheses; and finally, the assessment of low-field MRI in patients with suspicious prostate lesions on high-field MRI (3T).
The goal is to find an accessible solution for prostate cancer screening while maintaining or improving image quality.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Work Package1 (WP): 0.55T MRI Protocol Development
- •Healthy male volunteers aged 18 and above.
- •Agree to be contacted for incidental findings
- •Signed informed consent
- •WP2: 0.55T Prostate MRI with patients with metallic implant(s)
- •Adult men (≥18 y.o) with 3T MRI reported as sub-diagnostic due to metallic implants
- •Signed informed Consent
- •WP3: 0.55T Prostate MRI with patients with suspicious lesion(s)
- •Adult men (≥18 y.o)
- •PI-RADS 4/5 lesions detected on 3T MRI, schedules for targeted biopsy
- •Signed informed consent
排除标准
- •WP1: 0.55T MRI Protocol Development
- •Individuals with a history of prostate cancer
- •MR Contraindications as listed in the MR Safety Screening form
- •WP2: 0.55T Prostate MRI with patients with metallic implant(s)
- •Contraindications as per MD instructions
- •Any condition making the patient unsuitable for the study
- •Refusal to be notified in case of incidental finding on the examination
- •WP3: 0.55T Prostate MRI with patients with suspicious lesion(s)
- •Individuals with a history of prostate cancer.
- •Contraindications as per MD instructions
- •Any condition making the patient unsuitable for the study
- •Refusal to be notified in case of incidental finding on the examination
结局指标
主要结局
Evaluate the diagnostic accuracy of 0.55T MRI in detecting prostate suspicious lesions using the PI-RADS grading score, with the results of as the reference standard.
时间窗: 9 months
Assess the overall quality of prostate MR images obtained with 0.55T compared to 3T MRI in patients with suspected prostate cancer, using metrics of SNR, CNR and the PI-QUAL scaling score. Evaluate the diagnostic accuracy of 0.55T MRI in detecting prostate suspicious lesions using the PI-RADS grading score, with the results of a targeted prostate biopsy as the reference.
次要结局
- Image quality on patients with metal implants(9 months)
- Protocol optimization on healthy volunteers(1 month)
研究者
Naik Vietti Violi
Principal-Investigator, Executive Physician of Diagnostic And Interventional Radiology Department
University of Lausanne Hospitals