Perfusion Magnetic Resonance Imaging in Diagnosing Patients With Kidney Tumors

Stage IV Renal Cell Cancer Clinical Trial

Official title:

Pilot Study of Renal Neoplasms With Perfusion Magnetic Resonance Imaging

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02526511
• Other study ID #: 081407
• Secondary ID: NCI-2015-00848Pr
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 15, 2015
• Est. completion date: September 7, 2025

Study information

• Verified date: April 2023
• Source: Rutgers, The State University of New Jersey
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 75
• Est. completion date: September 7, 2025
• Est. primary completion date: July 28, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Renal Cell
• Stage I Renal Cell Cancer
• Stage II Renal Cell Cancer
• Stage III Renal Cell Cancer
• Stage IV Renal Cell Cancer

Intervention

Procedure:
• 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

Locations

Country	Name	City	State
United States	Rutgers Cancer Institute of New Jersey	New Brunswick	New Jersey

Sponsors (3)

Lead Sponsor	Collaborator
Rutgers, The State University of New Jersey	National Cancer Institute (NCI), Rutgers Cancer Institute of New Jersey

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Progression free survival	Kaplan-Meier survival curves will be performed to compare groups of patients to assess progression-free survival.	Up to 6 months
Primary	Sensitivity of pMRI	If possible, receiver operating characteristic curves will be created from pMRI data.	Up to 6 months
Primary	Specificity of pMRI	If possible, receiver operating characteristic curves will be created from pMRI data.	Up to 6 months
Primary	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
Primary	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