Perfusion Magnetic Resonance Imaging in Diagnosing Patients With Kidney Tumors
Pilot Study of Renal Neoplasms With Perfusion Magnetic Resonance Imaging
4 other identifiers
interventional
75
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2015
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 15, 2015
CompletedFirst Submitted
Initial submission to the registry
July 7, 2015
CompletedFirst Posted
Study publicly available on registry
August 18, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 28, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
September 7, 2025
CompletedApril 11, 2023
April 1, 2023
10.3 years
July 7, 2015
April 10, 2023
Conditions
Outcome Measures
Primary Outcomes (6)
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.
Up to 6 months
Study Arms (1)
Diagnostic (pMRI)
EXPERIMENTALPatients 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.
Interventions
Undergo arterial spin labeled perfusion magnetic resonance imaging
Undergo dynamic contrast-enhanced perfusion magnetic resonance imaging
Undergo dynamic susceptibility contrast-enhanced perfusion magnetic resonance imaging
Undergo perfusion magnetic resonance imaging
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Rutgers, The State University of New Jerseylead
- National Cancer Institute (NCI)collaborator
- Rutgers Cancer Institute of New Jerseycollaborator
Study Sites (1)
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
David Foran
Rutgers Cancer Institute of New Jersey
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PROF-TE-DIR, CINJ-BIOINFORMATICS
Study Record Dates
First Submitted
July 7, 2015
First Posted
August 18, 2015
Study Start
April 15, 2015
Primary Completion
July 28, 2025
Study Completion
September 7, 2025
Last Updated
April 11, 2023
Record last verified: 2023-04
Data Sharing
- IPD Sharing
- Will not share