Renal Malignant Tumor
Conditions
Brief summary
Patients with renal lesions suspicious for renal cell carcinoma (RCC) have a variety of different treatment pathways available to them. Imaging surveillance is being used frequently on smaller renal masses, and radiologists are being asked to biopsy more renal lesions to better guide decision making by urology. This is in large part due to the pathologic grade of renal masses having been shown to correlate with patient outcomes. The World Health Organization (WHO) or Fuhrman grade is the standard grading scale used by pathologists for RCC. The goal of this study will be to correlate contrast enhanced ultrasound findings with the pathologic grade of RCC. Specifically, the investigators hypothesize that tumors with different pathologic grades will show different patterns of qualitative enhancement, as well as different perfusion kinetics.
Detailed description
Renal malignancies are relatively common, with lifetime risk ranging from 1 in 48 in men to 1 in 83 in women, of which RCC is the most common. RCC comes in a variety of subtypes, and pathologic grade has been shown to be one factor that correlates with patient prognosis \[Novara et al\]. The most commonly used pathologic grading systems are the WHO or Fuhrman scale, which rely on histologic features of the tumor such as nuclear size, irregularity, and nucleolar prominence. Care of patients with RCC depends on a number of factors, including size and pathologic grade. As such, radiologic surveillance with CT and MRI is common, and percutaneous biopsy of renal masses for the purpose of pathologic grading is also relatively common. While percutaneous biopsy of renal masses is the least invasive way to obtain tissue, these still carry risks, especially of hemorrhage give the vascular nature of the kidneys and RCC. Contrast enhanced ultrasound has been shown to have the ability to differentiate renal masses from normal background renal parenchyma \[Barr et al\]. It has the unique ability to be used in patients with renal dysfunction as it is excreted by the liver and lungs. As such, it is well suited for use in patients with underlying renal pathology. This study will aim to use contrast enhanced ultrasound to evaluate the qualitative and quantitative features of renal masses prior to surgical removal, and then evaluate for correlation of these features with pathologic grading following surgery.
Interventions
DRUGContrast enhanced ultrasound with Lumason
Following consent, they will undergo contrast enhanced ultrasound of their known renal mass(es). This will be performed at University hospital following intravenous administration of Lumason (2.5 mL per injection, maximum of 2 injections per mass).
Sponsors
Indiana University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Masking description
Imaging reviewers will be blinded to pathologic grade
Intervention model description
Imaging findings for enrolled patients will be compared to pathologic grading
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Greater than or equal to 18 years of age * Previously identified renal mass with radiology and clinical features consistent with RCC * Clinical care plan includes partial or total nephrectomy
Exclusion criteria
* Less than 18 years of age * Currently pregnant * Renal mass with clinical care plan that does not include nephrectomy * Renal mass suspected to be non RCC neoplasm by imaging and clinical data * Renal mass unable to be visualized by grayscale ultrasound * Known renal vein thrombosis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Contrast Enhanced Ultrasound Features of Renal Masses (Time to Peak, Mean Transit Time) | 6 months | Ultrasound images will be reviewed for quantitative post contrast features (time to peak, mean transit time) |
| Contrast Enhanced Ultrasound Features of Renal Masses (Peak Intensity) | 6 months | Ultrasound images will be reviewed for quantitative post contrast features. Specifically peak intensity, which is measured in enhancement units. A higher value represents more blood flow to the renal mass. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Renal Malignancy Patients with renal mass(es) identified by cross sectional imaging, specifically ultrasound following the intravenous injection of Lumason
Contrast enhanced ultrasound with Lumason: Following consent, they will undergo contrast enhanced ultrasound of their known renal mass(es). This will be performed at University hospital following intravenous administration of Lumason (2.5 mL per injection, maximum of 2 injections per mass). | 12 |
| Total | 12 |
Baseline characteristics
| Characteristic | Renal Malignancy | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 3 Participants | — |
| Age, Categorical Between 18 and 65 years | 9 Participants | — |
| Lesion pathology Oncocytoma | 2 participants | — |
| Lesion pathology WHO grade 2 lesion | 6 participants | — |
| Lesion pathology WHO grade 3 lesion | 1 participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 4 Participants | — |
| Sex: Female, Male Male | 8 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 9 |
| other Total, other adverse events | 0 / 9 |
| serious Total, serious adverse events | 0 / 9 |
Outcome results
Primary
Contrast Enhanced Ultrasound Features of Renal Masses (Peak Intensity)
Ultrasound images will be reviewed for quantitative post contrast features. Specifically peak intensity, which is measured in enhancement units. A higher value represents more blood flow to the renal mass.
Time frame: 6 months
Population: 9 patients who completed enrollment and proceeded to surgery; staffing and software issues precluded acquisition of quantifiable ultrasound data on all but 1 of the patients who proceeded to surgery
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Renal Malignancy | Contrast Enhanced Ultrasound Features of Renal Masses (Peak Intensity) | 2.26 enhancement units |
Primary
Contrast Enhanced Ultrasound Features of Renal Masses (Time to Peak, Mean Transit Time)
Ultrasound images will be reviewed for quantitative post contrast features (time to peak, mean transit time)
Time frame: 6 months
Population: 9 patients who completed enrollment and proceeded to surgery; staffing and software issues precluded acquisition of quantifiable ultrasound data on all but 1 of the patients who proceeded to surgery
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Renal Malignancy | Contrast Enhanced Ultrasound Features of Renal Masses (Time to Peak, Mean Transit Time) | Time to peak enhancement (seconds) | 4.76 seconds |
| Renal Malignancy | Contrast Enhanced Ultrasound Features of Renal Masses (Time to Peak, Mean Transit Time) | Mean transit time (seconds) | 32.1 seconds |