The Enhancement of Diagnostic and Grading Efficacy of Prostate Cancer by New MRI Sequences: A Prospective Observational Study Based on New MRI Sequences in a Single Center
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Microstructure parameters related to the OGSE sequence
研究概览
简要总结
The goal of this clinical trial aims to explore the diagnostic efficacy and grading of prostate cancer by a novel MRI sequences such as MAGiC，OGSE,CEST,IVIM,etc.The main question it aims to answer is:
Can the novel non-contrast multiparametric MRI imaging improve the accuracy of diagnosis and grading of prostate cancer? For patients with clinical suspicion of prostate cancer, both conventional and new sequences magnetic resonance scans are conducted, with surgical or biopsy pathological results serving as the gold standard.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 90 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patients with a high clinical suspicion of prostate cancer and elevated tPSA levels;
- •Patients with no prior history of other tumors;
- •Patients with no contraindications to MRI, including claustrophobia, presence of pacemakers, cardiac stents, or metal implants such as screws and plates.
排除标准
- •The patient has a history of malignant tumors and has received corresponding treatment;
- •Prior to the MRI examination, the patient has undergone treatment for prostate cancer, including endocrine therapy, radiotherapy, etc.;
- •Patients who have previously undergone radical prostatectomy for prostate cancer.
研究组 & 干预措施
the categorie is GG1 according to the ISUP grading standard
干预措施: observational study (Other)
the categorie is GG2 according to the ISUP grading standard
干预措施: observational study (Other)
the categorie is GG3 according to the ISUP grading standard
干预措施: observational study (Other)
the categorie is GG4 according to the ISUP grading standard
干预措施: observational study (Other)
the categorie is GG5 according to the ISUP grading standard
干预措施: observational study (Other)
结局指标
主要结局
Microstructure parameters related to the OGSE sequence
时间窗: Within one week after the MRI scan
CEST sequence-related numerical values
时间窗: Within one week after the MRI scan
MAGIC sequence-related numerical values
时间窗: Within one week after the MRI scan
IVIM sequence-related numerical values
时间窗: Within one week after the MRI scan
次要结局
- Regular sequence-related numerical values(Within one week after the MRI scan)