Correlation of Renal Mass Pathologic Grade and CEUS
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|ClinicalTrials.gov Identifier: NCT03821376|
Recruitment Status : Recruiting
First Posted : January 29, 2019
Last Update Posted : February 11, 2020
|Condition or disease||Intervention/treatment||Phase|
|Renal Malignant Tumor||Drug: Contrast enhanced ultrasound with Lumason||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Imaging findings for enrolled patients will be compared to pathologic grading|
|Masking:||None (Open Label)|
|Masking Description:||Imaging reviewers will be blinded to pathologic grade|
|Official Title:||Correlation of Contrast Enhanced Ultrasound of Renal Masses With Pathologic Grade: A Prospective Comparison of Quantitative and Qualitative Findings|
|Actual Study Start Date :||July 16, 2019|
|Estimated Primary Completion Date :||July 1, 2020|
|Estimated Study Completion Date :||July 1, 2021|
Experimental: Renal malignancy
Patients with renal mass(es) identified by cross sectional imaging, specifically ultrasound following the intravenous injection of Lumason
Drug: 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).
Other Name: Ultrasound
- Correlation of contrast enhanced ultrasound features of renal masses with pathologic grade [ Time Frame: first 6 months ]Ultrasound images will be reviewed for qualitative imaging features as well as quantitative post contrast features (time to peak, area under the curve, mean transit time etc). These findings will then be correlated with the pathologic grade of surgically removed renal masses, to evaluate for differences in imaging features among the different pathologic grades.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03821376
|Contact: Jordan Swensson, MDfirstname.lastname@example.org|
|Contact: SaraH Munson, RNemail@example.com|
|United States, Indiana|
|Indiana University Hospital||Recruiting|
|Indianapolis, Indiana, United States, 46022|
|Contact: Sarah Munson 317-963-0305 firstname.lastname@example.org|