Stage I Renal Cell CancerNCT02526511

Perfusion Magnetic Resonance Imaging in Diagnosing Patients With Kidney Tumors

A study testing Arterial Spin Labeling Magnetic Resonance Imaging, Dynamic Contrast-Enhanced Magnetic Resonance Imaging and Dynamic Susceptibility Contrast-Enhanced Magnetic Resonance Imaging in people with Stage I Renal Cell Cancer and Stage II Renal Cell Cancer, run by Rutgers, The State University of New Jersey at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Stage I Renal Cell Cancer, Stage II Renal Cell Cancer, Stage III Renal Cell Cancer
What is being tested?: Arterial Spin Labeling Magnetic Resonance Imaging, Dynamic Contrast-Enhanced Magnetic Resonance Imaging and Dynamic Susceptibility Contrast-Enhanced Magnetic Resonance Imaging
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 75 participants
Where: 1 siteUnited States
Study dates: Apr 2015to Sep 2023
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903

Other trials in United States

About this study

Official title: Pilot Study of Renal Neoplasms With Perfusion Magnetic Resonance Imaging

Read the detailed description

PRIMARY OBJECTIVES:

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:

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: Stage I Renal Cell Cancer, Stage II Renal Cell Cancer, Stage III Renal Cell Cancer, Stage IV Renal Cell Cancer
Being tested: Arterial Spin Labeling Magnetic Resonance Imaging, Dynamic Contrast-Enhanced Magnetic Resonance Imaging, Dynamic Susceptibility Contrast-Enhanced Magnetic Resonance Imaging, Perfusion Magnetic Resonance Imaging
Medical subject headings: Carcinoma, Renal Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Arterial Spin Labeling Magnetic Resonance ImagingProcedure or surgery
Also called ARTERIAL SPIN LABELING FUNCTIONAL MRI, Arterial Spin Labeling MRI, ASL, ASL fMRI
Undergo arterial spin labeled perfusion magnetic resonance imaging
Dynamic Contrast-Enhanced Magnetic Resonance ImagingProcedure or surgery
Also called DCE MRI, DCE-MRI, DYNAMIC CONTRAST ENHANCED MRI
Undergo dynamic contrast-enhanced perfusion magnetic resonance imaging
Dynamic Susceptibility Contrast-Enhanced Magnetic Resonance ImagingProcedure or surgery
Also called Dynamic Susceptibility Contrast-Enhanced MRI
Undergo dynamic susceptibility contrast-enhanced perfusion magnetic resonance imaging
Perfusion Magnetic Resonance ImagingProcedure or surgery
Also called magnetic resonance perfusion imaging
Undergo perfusion magnetic resonance imaging

Study groups in NCT02526511
Study group	Role	What they receive
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. Receives: Procedure: Arterial Spin Labeling Magnetic Resonance Imaging; Procedure: Dynamic Contrast-Enhanced Magnetic Resonance Imaging; Procedure: Dynamic Susceptibility Contrast-Enhanced Magnetic Resonance Imaging; Procedure: Perfusion Magnetic Resonance Imaging

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Up to 6 months
Progression free survival
Kaplan-Meier survival curves will be performed to compare groups of patients to assess progression-free survival.
Measured: Up to 6 months
Sensitivity of pMRI
If possible, receiver operating characteristic curves will be created from pMRI data.
Measured: Up to 6 months
Specificity of pMRI
If possible, receiver operating characteristic curves will be created from pMRI data.
Measured: 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.
Measured: 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.
Measured: Up to 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2015Sep 2023

First posted18 Aug 2015 (estimated)
Study startApr 2015
Primary completionSep 2016
Study completionSep 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Stage I Renal Cell CancerStudies of the same condition, open and under way.
More trials run by Rutgers, The State University of New JerseyThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 75 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02526511
Sponsor's protocol ID: 081407
Other IDs: NCI-2015-00848, Pro2013003918, P30CA072720
Status last verified: May 2026
First submitted: 7 Jul 2015
Last updated: 2 Jun 2026
Results posted: No
Data monitoring committee: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Active, not recruitingPhase 1/2
Eribulin Mesylate in Treating Patients With Locally Advanced or Metastatic Cancer of the Urothelium and Kidney Dysfunction
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RecruitingPhase 2
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Renal Cell Carcinoma Stage I

All Stage I Renal Cell Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Pilot Study of Renal Neoplasms With Perfusion Magnetic Resonance Imaging
ClinicalTrials.gov ID: NCT02526511
Acronym / sponsor ID: 081407
Conditions: Stage I Renal Cell Cancer, Stage II Renal Cell Cancer, Stage III Renal Cell Cancer, Stage IV Renal Cell Cancer
Study type: Interventional
Recruitment status: Completed
Enrolment: 75 participants (actual)
Lead sponsor: Rutgers, The State University of New JerseyUniversity, hospital or other
Collaborators: National Cancer Institute (NCI), Rutgers Cancer Institute of New Jersey
Study start: Apr 2015 (actual)
Primary completion: Sep 2016 (actual)
Study completion: Sep 2023 (actual)
First posted: 18 Aug 2015 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

PRIMARY OBJECTIVES:

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.

SECONDARY OBJECTIVES:

To investigate the utility of pMRI to predict tumor grade and histologic subtype of organ confined kidney cancers.

OUTLINE:

After completion of study, patients are followed up within 48 hours.

Study design

Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Diagnostic (pMRI)	Experimental	Procedure: Arterial Spin Labeling Magnetic Resonance Imaging, Procedure: Dynamic Contrast-Enhanced Magnetic Resonance Imaging, Procedure: Dynamic Susceptibility Contrast-Enhanced Magnetic Resonance Imaging, Procedure: Perfusion Magnetic Resonance ImagingPatients 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Arterial Spin Labeling Magnetic Resonance ImagingAlso: ARTERIAL SPIN LABELING FUNCTIONAL MRI, Arterial Spin Labeling MRI, ASL, ASL fMRIUndergo arterial spin labeled perfusion magnetic resonance imaging	Procedure or surgery	Diagnostic (pMRI)
Dynamic Contrast-Enhanced Magnetic Resonance ImagingAlso: DCE MRI, DCE-MRI, DYNAMIC CONTRAST ENHANCED MRIUndergo dynamic contrast-enhanced perfusion magnetic resonance imaging	Procedure or surgery	Diagnostic (pMRI)
Dynamic Susceptibility Contrast-Enhanced Magnetic Resonance ImagingAlso: Dynamic Susceptibility Contrast-Enhanced MRIUndergo dynamic susceptibility contrast-enhanced perfusion magnetic resonance imaging	Procedure or surgery	Diagnostic (pMRI)
Perfusion Magnetic Resonance ImagingAlso: magnetic resonance perfusion imagingUndergo perfusion magnetic resonance imaging	Procedure or surgery	Diagnostic (pMRI)

Primary outcome

Perfusion MRI outputs
Time frame: 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
Time frame: Up to 6 months
Kaplan-Meier survival curves will be performed to compare groups of patients to assess progression-free survival.
Sensitivity of pMRI
Time frame: Up to 6 months
If possible, receiver operating characteristic curves will be created from pMRI data.
Specificity of pMRI
Time frame: Up to 6 months
If possible, receiver operating characteristic curves will be created from pMRI data.
Tumor histopathology
Time frame: 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
Time frame: 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.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2026.
Individual participant dataSharing planned: No

Related trials for Stage I Renal Cell Cancer

Active, not recruitingPhase 1/2
Pazopanib Hydrochloride and Bevacizumab in Treating Patients With Previously Untreated Metastatic Kidney Cancer
Clear Cell Renal Cell Carcinoma, Stage IV Renal Cell Cancer
RecruitingObservational study
Collecting Blood Samples From Patients With and Without Cancer to Evaluate Tests for Early Cancer Detection
Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia
RecruitingPhase 1/2
Administering Peripheral Blood Lymphocytes Transduced With a CD70-Binding Chimeric Antigen Receptor to People With CD70 Expressing Cancers
Pancreatic Cancer, Renal Cell Cancer
Active, not recruitingPhase 1/2
Eribulin Mesylate in Treating Patients With Locally Advanced or Metastatic Cancer of the Urothelium and Kidney Dysfunction
Advanced Urothelial Carcinoma, Locally Advanced Urothelial Carcinoma
RecruitingPhase 2
An Exploratory Study on the Failure of Immunotherapy With Vorolanib Combined With Everolimus
Renal Cell Carcinoma Stage I

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

David Foran principal investigator

Rutgers Cancer Institute of New Jersey

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Perfusion MRI outputs (time frame: Up to 6 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02526511.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2026.