Pilot Study of Renal Neoplasms With Perfusion Magnetic Resonance Imaging
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 2
- 主要终点
- Progression free survival
研究概览
简要总结
This pilot clinical trial studies perfusion magnetic resonance imaging in diagnosing patients with kidney tumors. Diagnostic procedures, such as perfusion magnetic resonance imaging, may help find and diagnose kidney tumors and predict and monitor a patient's response to treatment.
详细描述
PRIMARY OBJECTIVES:
I. To investigate the utility of perfusion magnetic resonance imaging (pMRI) as a diagnostic biomarker for the prediction of malignant vs. benign organ confined renal masses.
II. To investigate the utility of pMRI as a therapeutic biomarker for monitoring tumor progression in patients undergoing treatment (ablation, surgery, specific systemic treatments such as interleukin 2 (IL-2) or vascular endothelial growth factor [VEGF]/vascular endothelial growth factor receptor [VEGFR]/mechanistic target of rapamycin [mTOR] targeted therapies) or active surveillance for organ confined or metastatic renal tumors.
SECONDARY OBJECTIVES:
I. To investigate the utility of pMRI to predict tumor grade and histologic subtype of organ confined kidney cancers.
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 must be able to read, understand, and voluntarily sign an informed consent document
- •For patients with organ confined renal tumors to be enrolled, the renal mass must be >= 1 cm in diameter on computed tomography (CT) or magnetic resonance imaging (MRI) and can be any clinical stage T1a-T4 (non-metastatic); a histologic diagnosis is not required for enrollment; the primary imaging site would be kidney
- •For patients with metastatic renal tumors to be enrolled, a histologic diagnosis of renal cell carcinoma must exist and any burden of disease >= 1 cm by CT or MRI is acceptable; the metastatic sites may be kidney, intra-abdominal (such as liver), brain, bone, or lymph nodes; lung lesions are NOT eligible because of the motion artifact caused by respiration
- •Patients with metastatic disease may have received prior nephrectomy and/or prior systemic therapy (no limit on number); their baseline pMRI would be performed prior to starting a new treatment
- •Negative pregnancy test if female of child-bearing age
- •Able to undergo contrast enhanced MRI
排除标准
- •Severe concurrent disease, infection, or medical co-morbidity that, in the judgment of the investigator, would make the patient inappropriate for enrollment
- •Severe renal function impairment (estimated glomerular filtration rate [eGFR] < 45 mL/min/1.73 m^2) would make the patient inappropriate for enrollment due to the increased risk of nephrogenic systemic fibrosis (NSF) with higher dose of IV gadolinium-based contrast agents (GBCA) administration
- •Women who are pregnant or breastfeeding
- •Subjects who are unable to tolerate or are not eligible for MR imaging (claustrophobia, metal implantable devices such as pacemaker, aneurysm clips, etc)
- •Subjects with established allergy to IV GBCA
研究组 & 干预措施
Diagnostic (pMRI)
Patients undergo DCE, DSC, or ASL pMRI within 30 days of biopsy or surgery. Patients with organ confined tumors selected for active surveillance or surgery and patients with metastatic renal cell carcinoma undergo follow up pMRI at 1-6 months.
干预措施: Arterial Spin Labeling Magnetic Resonance Imaging (Procedure)
Diagnostic (pMRI)
Patients undergo DCE, DSC, or ASL pMRI within 30 days of biopsy or surgery. Patients with organ confined tumors selected for active surveillance or surgery and patients with metastatic renal cell carcinoma undergo follow up pMRI at 1-6 months.
干预措施: Dynamic Contrast-Enhanced Magnetic Resonance Imaging (Procedure)
Diagnostic (pMRI)
Patients undergo DCE, DSC, or ASL pMRI within 30 days of biopsy or surgery. Patients with organ confined tumors selected for active surveillance or surgery and patients with metastatic renal cell carcinoma undergo follow up pMRI at 1-6 months.
干预措施: Dynamic Susceptibility Contrast-Enhanced Magnetic Resonance Imaging (Procedure)
Diagnostic (pMRI)
Patients undergo DCE, DSC, or ASL pMRI within 30 days of biopsy or surgery. Patients with organ confined tumors selected for active surveillance or surgery and patients with metastatic renal cell carcinoma undergo follow up pMRI at 1-6 months.
干预措施: Perfusion Magnetic Resonance Imaging (Procedure)
结局指标
主要结局
Progression free survival
时间窗: Up to 6 months
Kaplan-Meier survival curves will be performed to compare groups of patients to assess progression-free survival.
Specificity of pMRI
时间窗: Up to 6 months
If possible, receiver operating characteristic curves will be created from pMRI data.
Perfusion MRI outputs
时间窗: Up to 6 months
Univariate and multivariate analyses will be performed to look for associations between pMRI outputs and tumor histopathology. The utilization of perfusion MRI as a diagnostic biomarker for tumor grade and histological subtype will be assessed by correlative comparison to histological evaluation by pathology.
Sensitivity of pMRI
时间窗: Up to 6 months
If possible, receiver operating characteristic curves will be created from pMRI data.
Tumor histopathology
时间窗: Up to 6 months
Univariate and multivariate analyses will be performed to look for associations between pMRI outputs and tumor histopathology. The utilization of perfusion MRI as a diagnostic biomarker for tumor grade and histological subtype will be assessed by correlative comparison to histological evaluation by pathology.
Progression free survival and/or radiographic tumor evaluation
时间窗: Up to 6 months
The utility of pMRI as a therapeutic biomarker for monitoring or predicting treatment response will be assessed by correlative comparison to progression free survival and/or radiographic tumor evaluation by standard of care radiologic imaging modality, such as Response Evaluation Criteria in Solid Tumors.
次要结局
未报告次要终点
研究者
David Foran
PROF-TE-DIR, CINJ-BIOINFORMATICS
Rutgers Cancer Institute of New Jersey