Advanced Diffusion Imaging in Renal Cancer Patients: Oncologic Control and Renal Functional Reserve
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- Percentage of Times Lesion Type is Correctly Predicted using IVIM-MRI at Pre-Surgery
研究概览
简要总结
The objective of this study is to apply advanced diffusion imaging in a two-pronged assessment of renal mass patients: (1) characterization of lesion malignancy and subtype, and (2) prediction of renal function stability or decline following partial nephrectomy.
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
- 21 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Renal mass patients scheduled for laparoscopic partial nephrectomy.
- •eGFR above 30 ml/min/m
- •Ages 21 to 85
- •Must be willing and able to provide consent.
排除标准
- •All metal implants and dental implants that have ferromagnetic properties and are unsafe at 3.0 T.
- •Pregnant women are not eligible for participating in this study.
- •Acute claustrophobia
研究组 & 干预措施
Renal Mass Patients
Patients will be enrolled for 2 MRI visits. These visits will include an approximately 1 hour research MRI scan and a total of between 3 and 5 hours Tc-99m DTPA scan.
In each MRI visit, patients will be scanned for approximately one hour including both standard-of-care clinical sequences and research-based Advanced Diffusion Imaging sequences, on a Prisma 3T MRI scanner. Following the MRI exam or on a day not more than a week after the MRI exam, patients will undergo renal function assessment via Tc-99m DTPA scan and patient's kidneys will be scanned using a gamma camera. Proteinuria will be assessed by standard of care urinalysis of specimens collected at each MRI visit for each patient. Blood test will be performed at each visit to estimate GFR (eGFR) from measurement of serum creatinine.
干预措施: Magnetic Resonance Imaging (MRI) Scan (Device)
Renal Mass Patients
Patients will be enrolled for 2 MRI visits. These visits will include an approximately 1 hour research MRI scan and a total of between 3 and 5 hours Tc-99m DTPA scan.
In each MRI visit, patients will be scanned for approximately one hour including both standard-of-care clinical sequences and research-based Advanced Diffusion Imaging sequences, on a Prisma 3T MRI scanner. Following the MRI exam or on a day not more than a week after the MRI exam, patients will undergo renal function assessment via Tc-99m DTPA scan and patient's kidneys will be scanned using a gamma camera. Proteinuria will be assessed by standard of care urinalysis of specimens collected at each MRI visit for each patient. Blood test will be performed at each visit to estimate GFR (eGFR) from measurement of serum creatinine.
干预措施: Tc-99m Pentetate (Drug)
结局指标
主要结局
Percentage of Times Lesion Type is Correctly Predicted using IVIM-MRI at Pre-Surgery
时间窗: Baseline (1 Week Prior to Operation)
Intravoxel incoherent imaging-MRI (IVIM-MRI) data will be used to predict lesion type.
次要结局
- Percentage of Times Post-Surgical Renal Function is Correctly Predicted Using REFMAP-MRI at Pre-Surgery(Up to Year 1 Post-Operation)