Clinical trial NCT02526511: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Stage I Renal Cell Cancer
Stage II Renal Cell Cancer
Stage III Renal Cell Cancer
Stage IV Renal Cell Cancer
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: Rutgers Cancer Institute of New Jersey
First posted: 2015-08-18
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Perfusion MRI outputs
timeFrame: Up to 6 months
measure: Progression free survival
timeFrame: Up to 6 months
measure: Sensitivity of pMRI
timeFrame: Up to 6 months
measure: Specificity of pMRI
timeFrame: Up to 6 months
measure: Tumor histopathology
timeFrame: Up to 6 months
measure: Progression free survival and/or radiographic tumor evaluation
timeFrame: Up to 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: New Brunswick
country: United States
facility: Rutgers Cancer Institute of New Jersey
state: New Jersey
Study officials:
affiliation: Rutgers Cancer Institute of New Jersey
name: David Foran
role: PRINCIPAL_INVESTIGATOR
References: