Skip to main content
OpenTrials
Completed

NCT Number: NCT02526511

Perfusion Magnetic Resonance Imaging in Diagnosing Patients With Kidney Tumors

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Stage I Renal Cell Cancer Adenocarcinoma Carcinoma Carcinoma, Renal Cell Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Neoplasms Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Stage II Renal Cell Cancer Stage III Renal Cell Cancer Stage IV Renal Cell Cancer Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, 08903, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Arterial Spin Labeling Magnetic Resonance Imaging

Procedure

Undergo arterial spin labeled perfusion magnetic resonance imaging

Other names: ARTERIAL SPIN LABELING FUNCTIONAL MRI, Arterial Spin Labeling MRI, ASL, ASL fMRI

Dynamic Contrast-Enhanced Magnetic Resonance Imaging

Procedure

Undergo dynamic contrast-enhanced perfusion magnetic resonance imaging

Other names: DCE MRI, DCE-MRI, DYNAMIC CONTRAST ENHANCED MRI

Dynamic Susceptibility Contrast-Enhanced Magnetic Resonance Imaging

Procedure

Undergo dynamic susceptibility contrast-enhanced perfusion magnetic resonance imaging

Other names: Dynamic Susceptibility Contrast-Enhanced MRI

Perfusion Magnetic Resonance Imaging

Procedure

Undergo perfusion magnetic resonance imaging

Other names: magnetic resonance perfusion imaging

Primary outcomes

  1. 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.

  2. 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.

  3. Sensitivity of pMRI

    Time frame: Up to 6 months

    If possible, receiver operating characteristic curves will be created from pMRI data.

  4. Specificity of pMRI

    Time frame: Up to 6 months

    If possible, receiver operating characteristic curves will be created from pMRI data.

  5. 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.

  6. 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.

Sponsors and collaborators

Lead sponsor

Rutgers, The State University of New Jersey

Other

Collaborators

  • National Cancer Institute (NCI)
  • Rutgers Cancer Institute of New Jersey

Registry information

Official study title

Pilot Study of Renal Neoplasms With Perfusion Magnetic Resonance Imaging

Important dates

Study start
2015
Primary completion
2016
Study completion
2023
First posted
Aug 18, 2015
Registry last updated
Jun 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.