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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2015-00848 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| Pro2013003918 | Other Identifier | Rutgers Cancer Institute of New Jersey | |
| P30CA072720 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| Rutgers Cancer Institute of New Jersey | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diagnostic (pMRI) | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Arterial Spin Labeling Magnetic Resonance Imaging | Procedure | Undergo arterial spin labeled perfusion magnetic resonance imaging |
|
| Measure | Description | Time Frame |
|---|---|---|
| Perfusion MRI outputs | 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. | Up to 6 months |
| Progression free survival | Kaplan-Meier survival curves will be performed to compare groups of patients to assess progression-free survival. | Up to 6 months |
| Sensitivity of pMRI | If possible, receiver operating characteristic curves will be created from pMRI data. | Up to 6 months |
| Specificity of pMRI | If possible, receiver operating characteristic curves will be created from pMRI data. | Up to 6 months |
| Tumor histopathology | 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. | Up to 6 months |
| Progression free survival and/or radiographic tumor evaluation | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Foran | Rutgers Cancer Institute of New Jersey | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rutgers Cancer Institute of New Jersey | New Brunswick | New Jersey | 08903 | United States |
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| Dynamic Contrast-Enhanced Magnetic Resonance Imaging | Procedure | Undergo dynamic contrast-enhanced perfusion magnetic resonance imaging |
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| Dynamic Susceptibility Contrast-Enhanced Magnetic Resonance Imaging | Procedure | Undergo dynamic susceptibility contrast-enhanced perfusion magnetic resonance imaging |
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| Perfusion Magnetic Resonance Imaging | Procedure | Undergo perfusion magnetic resonance imaging |
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| Up to 6 months |
| ID | Term |
|---|---|
| D002292 | Carcinoma, Renal Cell |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D007680 | Kidney Neoplasms |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
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