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Perfusion Magnetic Resonance Imaging in Diagnosing Patients With Kidney Tumors

Primary Purpose

Stage I Renal Cell Cancer, Stage II Renal Cell Cancer, Stage III Renal Cell Cancer

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Arterial Spin Labeling Magnetic Resonance Imaging
Dynamic Contrast-Enhanced Magnetic Resonance Imaging
Dynamic Susceptibility Contrast-Enhanced Magnetic Resonance Imaging
Perfusion Magnetic Resonance Imaging
Sponsored by
Rutgers, The State University of New Jersey
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Stage I Renal Cell Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • Rutgers Cancer Institute of New Jersey

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Diagnostic (pMRI)

Arm Description

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.

Outcomes

Primary Outcome Measures

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.
Progression free survival
Kaplan-Meier survival curves will be performed to compare groups of patients to assess progression-free survival.
Sensitivity of pMRI
If possible, receiver operating characteristic curves will be created from pMRI data.
Specificity of pMRI
If possible, receiver operating characteristic curves will be created from pMRI data.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
July 7, 2015
Last Updated
April 10, 2023
Sponsor
Rutgers, The State University of New Jersey
Collaborators
National Cancer Institute (NCI), Rutgers Cancer Institute of New Jersey
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1. Study Identification

Unique Protocol Identification Number
NCT02526511
Brief Title
Perfusion Magnetic Resonance Imaging in Diagnosing Patients With Kidney Tumors
Official Title
Pilot Study of Renal Neoplasms With Perfusion Magnetic Resonance Imaging
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 15, 2015 (Actual)
Primary Completion Date
July 28, 2025 (Anticipated)
Study Completion Date
September 7, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rutgers, The State University of New Jersey
Collaborators
National Cancer Institute (NCI), Rutgers Cancer Institute of New Jersey

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stage I Renal Cell Cancer, Stage II Renal Cell Cancer, Stage III Renal Cell Cancer, Stage IV Renal Cell Cancer

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
75 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Diagnostic (pMRI)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Arterial Spin Labeling Magnetic Resonance Imaging
Other Intervention Name(s)
ARTERIAL SPIN LABELING FUNCTIONAL MRI, Arterial Spin Labeling MRI, ASL, ASL fMRI
Intervention Description
Undergo arterial spin labeled perfusion magnetic resonance imaging
Intervention Type
Procedure
Intervention Name(s)
Dynamic Contrast-Enhanced Magnetic Resonance Imaging
Other Intervention Name(s)
DCE MRI, DCE-MRI, DYNAMIC CONTRAST ENHANCED MRI
Intervention Description
Undergo dynamic contrast-enhanced perfusion magnetic resonance imaging
Intervention Type
Procedure
Intervention Name(s)
Dynamic Susceptibility Contrast-Enhanced Magnetic Resonance Imaging
Other Intervention Name(s)
Dynamic Susceptibility Contrast-Enhanced MRI
Intervention Description
Undergo dynamic susceptibility contrast-enhanced perfusion magnetic resonance imaging
Intervention Type
Procedure
Intervention Name(s)
Perfusion Magnetic Resonance Imaging
Other Intervention Name(s)
magnetic resonance perfusion imaging
Intervention Description
Undergo perfusion magnetic resonance imaging
Primary Outcome Measure Information:
Title
Perfusion MRI outputs
Description
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.
Time Frame
Up to 6 months
Title
Progression free survival
Description
Kaplan-Meier survival curves will be performed to compare groups of patients to assess progression-free survival.
Time Frame
Up to 6 months
Title
Sensitivity of pMRI
Description
If possible, receiver operating characteristic curves will be created from pMRI data.
Time Frame
Up to 6 months
Title
Specificity of pMRI
Description
If possible, receiver operating characteristic curves will be created from pMRI data.
Time Frame
Up to 6 months
Title
Tumor histopathology
Description
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.
Time Frame
Up to 6 months
Title
Progression free survival and/or radiographic tumor evaluation
Description
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.
Time Frame
Up to 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Foran
Organizational Affiliation
Rutgers Cancer Institute of New Jersey
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rutgers Cancer Institute of New Jersey
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08903
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Perfusion Magnetic Resonance Imaging in Diagnosing Patients With Kidney Tumors

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