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Study stopped due to staffing issues that impacted ability to recruit.
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Renal malignancy | Experimental | Patients with renal mass(es) identified by cross sectional imaging, specifically ultrasound following the intravenous injection of Lumason |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Contrast enhanced ultrasound with Lumason | Drug | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 6 months |
| 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. | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jordan Swennson, MD | Indiana University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indiana University Hospital | Indianapolis | Indiana | 46022 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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) | 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 | Posted | Number | seconds | 6 months |
|
From enrollment to time of surgery (2 months)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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). |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jordan Swensson, MD | Indiana University | 317-944-1831 | jswensso@iu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 3, 2019 | Sep 12, 2024 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D002292 | Carcinoma, Renal Cell |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D019220 | High-Energy Shock Waves |
| ID | Term |
|---|---|
| D000069453 | Ultrasonic Waves |
| D013016 | Sound |
| D011840 | Radiation, Nonionizing |
| D011827 | Radiation |
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Imaging findings for enrolled patients will be compared to pathologic grading
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Imaging reviewers will be blinded to pathologic grade
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|
|
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Lesion pathology | Renal pathologic grading done following WHO grading system for renal cell carcinoma (RCC). Lesions may be considered grade 1-4, with 4 representing the most aggressive pathology appearance. Kidney lesions that are not RCC are not given a grade. | Number | participants |
|
|
|
| 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. | 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 | Posted | Number | enhancement units | 6 months |
|
|
|
| 0 |
| 9 |
| 0 |
| 9 |
| 0 |
| 9 |
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| D009369 | Neoplasms |
| D007680 | Kidney Neoplasms |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D055585 |
| Physical Phenomena |