Contrast-Enhanced Ultrasound for Kidney Cancer Subtyping and Staging
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|ClinicalTrials.gov Identifier: NCT04021238|
Recruitment Status : Not yet recruiting
First Posted : July 16, 2019
Last Update Posted : July 19, 2019
|Condition or disease||Intervention/treatment||Phase|
|Kidney Cancer||Drug: Perflutren lipid microsphere Drug: Sulfur hexafluoride lipid microspheres||Phase 4|
This is a pilot cross-sectional study that compares contrast enhanced ultrasound to conventional ultrasound and contrasted MRI. Eligible patients will include anyone who has suspected kidney cancer and is scheduled for surgery, up to an anticipated total of 40 participants. Subject participation will be only for the day of CEUS study. There will be no follow-up period for this study. However, if results are encouraging, a longitudinal observational study may follow, and these same subjects would be eligible for enrollment. Eligible subjects will undergo a contrast enhanced ultrasound.
Following completion of imaging, all CEUS, MRI (within 4 months) and B-mode (at time of CEUS) US studies will be de-identified. Blinded radiologists will interpret images and provide an overall assessment of risk of malignancy to each kidney using the Bosniak criteria for each kidney lesion present. The Bosniak criteria places cystic lesions into one of 5 categories (I, II, IIF, III and IV) based on lesion characteristics. CEUS based diagnosis will be compared to the diagnoses on routine B-mode US and contrast-enhanced MRI.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Contrast-Enhanced Ultrasound for Kidney Cancer Subtyping and Staging|
|Estimated Study Start Date :||September 2019|
|Estimated Primary Completion Date :||December 2021|
|Estimated Study Completion Date :||December 2021|
Experimental: Perflutren Lipid Microsphere or Lumason
Patients with suspected kidney cancer and planned surgery will be imaged using contrast-enhanced ultrasound with either perflutren or Lumason.
Drug: Perflutren lipid microsphere
Baseline B-mode US will be performed to confirm the lesions being imaged (unless it is a subject with no lesions, then a basic B-mode US will be performed. Perflutren is a diagnostic drug that is intended to be used for contrast enhancement. The vial contains a clear, colorless, sterile, non-pyrogenic, hypertonic solution which is activated by mechanical agitation with Vialmix®.It will be dispensed in inactivated form to a study team member. The contrast agent will be activated just prior to administration (ideally to be used within 5 minutes of activation). Contrast agent Definity (or Lumason) will be activated according to package insert instructions, including use of VialMix®, the device used to activate Definity. Administration will occur IV in coordination with sonography staff trained specifically in contrast ultrasound imaging.The total imaging time is anticipated to be less than 30 minutes.
Drug: Sulfur hexafluoride lipid microspheres
Baseline B-mode US will be performed to confirm the lesions being imaged (unless it is a subject with no lesions, then a basic B-mode US will be performed. Lumason will be used as a secondary contrast agent only if Definity(perflutren) is unavailable.This drug will be administered using the dosing range and administration type within the Lumason prescribing information. The contrast agent will be activated just prior to administration (ideally to be used within 5 minutes of activation). Contrast agent Definity (or Lumason) will be activated according to package insert instructions, including use of VialMix®, the device used to activate Definity. Administration will occur IV in coordination with sonography staff trained specifically in contrast ultrasound imaging.The total imaging time is anticipated to be less than 30 minutes.
Other Name: Lumason
- Predicting kidney mass diagnosis using 3D CEUS generated metrics [ Time Frame: (Baseline) ]A 3D volume of regions of interest (ROI) will be calculated using MATLAB. An overall score of each ROI will be derived from multiple parameters from CEUS, B-mode US, and patient factors. A hypothesis test with 95% confidence will be used to test the effects of individual parameters on a fitted logistic regression model to determine the added value of the CEUS measurements.
- Comparing diagnostic accuracy of F-R infusion imaging technique to low MI bolus imaging technique [ Time Frame: (Baseline) ]The model-building and evaluation strategy used for the primary objective will be used for bolus and infusion imaging modalities separately as well as in a combined multiparametric score. Standard errors will be obtained by bootstrapping correcting for the fact that both are derived from the same data and thus correlated.
- Predicting kidney mass stage using 3D CEUS-generated metrics [ Time Frame: (Baseline) ]The continuous variables WI and WO will be used to predict the binary measure of stage T3 or greater disease. We will calculate means (standard deviations) and 95% confidence intervals for WI and WO for those ≥ stage T3 vs. < stage T3, and compare via t-tests at alpha=.05. Logistic regression will be used to assess the abilities of WI and WO to predict stage T3 disease or greater, both separately and combined.
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): NCT04021238
|Contact: Shanah Kirkfirstname.lastname@example.org|
|Contact: Hannah Mignosaemail@example.com|
|United States, North Carolina|
|University of North Carolina at Chapel Hill||Not yet recruiting|
|Chapel Hill, North Carolina, United States, 27599|
|Contact: Shanah Kirk 919-966-6957 firstname.lastname@example.org|
|Contact: Hannah Mignosa 984-215-4963 email@example.com|
|Principal Investigator: Emily Chang, MD|
|Principal Investigator:||Emily Chang, MD||University of North Carolina, Chapel Hill|