Tumor Heterogeneity of Renal Tumors Assessed by Multiparametric MRI With Direct Radiological-histopathological Correlation: an Explorative Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Viable tumor fraction
研究概览
简要总结
In this study, high-resolution magnetic resonance imaging scans (MRI/mpMRI) were performed before surgical removal of the tumor and then compared with microscopic examinations of the tumor. Instead of looking at just one single area, the study compared many small, spatially correlated sections of the tumor-almost like creating a mini-map of the entire tumor.
详细描述
A prospective single-center pilot study was performed on patients with solid renal tumors ≥2cm undergoing nephrectomy. Each patient underwent advanced preoperative 3.0T-mpMRI (including T2-weighted, pre-/postcontrast T1-weighted sequences, CS imaging, IVIM-DWI, and mapping). Tumor regions were jointly defined by a pathologist and radiologist. Identical Regions of Interest (ROIs) were assessed across all sequences to derive quantitative mpMRI parameters. Histopathology provided quantified regional fractions: viable tumor, fibrosis, hemorrhage, and cystic/necrotic components. Associations between these parameters were evaluated using Spearman's rank correlation and univariable linear regression at the regional level.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with confirmed or suspected renal tumor with an approx. size of ≥ 2 cm who are scheduled for clinical MRI examination and surgical resection of the tumor
- •Informed consent as documented by signature (Informed Consent Form)
- •Patients ≥18 years of age
排除标准
- •Women who are pregnant or breast feeding
- •Intention to become pregnant during the course of the study and lack of safe contraception
- •Inability to follow the procedures of the study, e.g., due to language problems, psychological disorders, dementia, etc. of the participant
- •Previous enrolment into the current study
- •Enrolment of the investigator, his/her family members, employees and other dependent persons
- •Patients with non-MRI compatible metallic or electronic implants, devices or metallic foreign bodies (cardiac pacemaker, shrapnel, cochlea implants, neurostimulator, or other non-MRI compatible implants).
- •Patients with known hypersensitivity reactions to MRI contrast agents will undergo the examination without application of a contrast agent
结局指标
主要结局
Viable tumor fraction
时间窗: Baseline
Fraction of tumor that is viable
次要结局
未报告次要终点