Bridging Imaging and Pathology: Using Advanced MRI Protocols in Correlation With Extensive Histopathology to Detect Clinically Significant Prostate Cancer
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
- Comparison of different microstructure models in the performance of detecting csPCa
研究概览
简要总结
In recent years, new and promising approaches have emerged in the field of MRI imaging of the prostate. These approaches usually aim to visualise the so-called "microstructures" of the tissue and are intended to offer greater accuracy in the diagnosis of prostate cancer than the current mpMRI examination. To this end, mathematical microstructure models are calculated that determine the proportional presence of histological substructures in specific MRI volumes. Additional new MRI sequences that are not routinely recorded are required to calculate the microstructure models. In order to further investigate the possibilities of these new MRI sequences, this study will compare different mathematical models. In addition, a histopathological examination of the tissue will be performed.
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
- •Humans with a prostate ≥18 years of age.
- •Patients with biopsy-proven PCa who are scheduled for an RPE.
- •Signed informed consent form (ICF) that demonstrates study participant understands the purpose of and procedures necessary for the study.
- •Willingness, ability, and legal capacity to participate in the study.
- •Ability to adhere to the prohibitions and restrictions defined in this protocol.
排除标准
- •Inability to give consent.
- •Prior hormone treatment (i.e., androgen deprivation treatment (ADT) and/or 5-ɑ-reductase inhibitors).
- •Prior PCa treatment.
- •Prior transurethral resection of the prostate (TUR-P) or other prostate surgery.
- •Prior total hip arthroplasty on one or both sides or other metal implants that interfere with the MRI acquisition of the hip region.
- •General contraindications for an MRI scan (i.e., pacemaker, relevant metal implants, etc.).
研究组 & 干预措施
Patients with biopsy-proven PCa who are scheduled for RPE
结局指标
主要结局
Comparison of different microstructure models in the performance of detecting csPCa
时间窗: Upon study completion since data from all subjects need to be included (Until 6 months after the last patient got included)
次要结局
未报告次要终点