Perfusion Magnetic Resonance Imaging in Diagnosing Patients With Kidney Tumors
- Conditions
- Stage II Renal Cell CancerStage IV Renal Cell CancerStage I Renal Cell CancerStage III Renal Cell Cancer
- Interventions
- Procedure: Arterial Spin Labeling Magnetic Resonance ImagingProcedure: Dynamic Contrast-Enhanced Magnetic Resonance ImagingProcedure: Dynamic Susceptibility Contrast-Enhanced Magnetic Resonance ImagingProcedure: Perfusion Magnetic Resonance Imaging
- Registration Number
- NCT02526511
- Lead Sponsor
- Rutgers, The State University of New Jersey
- Brief Summary
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.
- Detailed Description
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.
OUTLINE:
Patients undergo dynamic contrast enhanced (DCE), dynamic susceptibility contrast (DSC), or arterial spin labeled (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.
After completion of study, patients are followed up within 48 hours.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 75
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Diagnostic (pMRI) Perfusion Magnetic Resonance Imaging 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. Diagnostic (pMRI) Arterial Spin Labeling Magnetic Resonance Imaging 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. Diagnostic (pMRI) Dynamic Contrast-Enhanced Magnetic Resonance Imaging 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. Diagnostic (pMRI) Dynamic Susceptibility Contrast-Enhanced Magnetic Resonance Imaging 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.
- Primary Outcome Measures
Name Time Method Progression free survival Up to 6 months Kaplan-Meier survival curves will be performed to compare groups of patients to assess progression-free survival.
Specificity of pMRI Up to 6 months If possible, receiver operating characteristic curves will be created from pMRI data.
Perfusion MRI outputs 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 Up to 6 months If possible, receiver operating characteristic curves will be created from pMRI data.
Tumor histopathology 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 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Rutgers Cancer Institute of New Jersey
🇺🇸New Brunswick, New Jersey, United States