Perfusion Magnetic Resonance Imaging in Diagnosing Patients With Kidney Tumors
NCT ID: NCT02526511
Last Updated: 2023-04-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
75 participants
INTERVENTIONAL
2015-04-15
2025-09-07
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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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.
Arterial Spin Labeling Magnetic Resonance Imaging
Undergo arterial spin labeled perfusion magnetic resonance imaging
Dynamic Contrast-Enhanced Magnetic Resonance Imaging
Undergo dynamic contrast-enhanced perfusion magnetic resonance imaging
Dynamic Susceptibility Contrast-Enhanced Magnetic Resonance Imaging
Undergo dynamic susceptibility contrast-enhanced perfusion magnetic resonance imaging
Perfusion Magnetic Resonance Imaging
Undergo perfusion magnetic resonance imaging
Interventions
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Arterial Spin Labeling Magnetic Resonance Imaging
Undergo arterial spin labeled perfusion magnetic resonance imaging
Dynamic Contrast-Enhanced Magnetic Resonance Imaging
Undergo dynamic contrast-enhanced perfusion magnetic resonance imaging
Dynamic Susceptibility Contrast-Enhanced Magnetic Resonance Imaging
Undergo dynamic susceptibility contrast-enhanced perfusion magnetic resonance imaging
Perfusion Magnetic Resonance Imaging
Undergo perfusion magnetic resonance imaging
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Rutgers Cancer Institute of New Jersey
OTHER
Rutgers, The State University of New Jersey
OTHER
Responsible Party
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David Foran
PROF-TE-DIR, CINJ-BIOINFORMATICS
Principal Investigators
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David Foran
Role: PRINCIPAL_INVESTIGATOR
Rutgers Cancer Institute of New Jersey
Locations
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Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States
Countries
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Other Identifiers
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NCI-2015-00848
Identifier Type: REGISTRY
Identifier Source: secondary_id
Pro2013003918
Identifier Type: OTHER
Identifier Source: secondary_id
081407
Identifier Type: -
Identifier Source: org_study_id
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