Phase 2
N=24
Contrast-Enhanced Ultrasound for Kidney Cancer Subtyping and Staging
Kidney Cancer
Bottom Line
View on ClinicalTrials.gov: NCT04021238 ↗Enrolled (actual)
24
Serious AEs
0.0%
Results posted
Nov 2023
Primary outcome: Primary: 3D CEUS Generated Metrics in Kidney Mass: Wash_In_Slope — 7.60 AU/second
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Perflutren lipid microsphere (Drug); Sulfur hexafluoride lipid microspheres (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- UNC Lineberger Comprehensive Cancer Center
- Primary completion
- Aug 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 3D CEUS Generated Metrics in Kidney Mass: Wash_In_Slope |
7.60 | — |
| PRIMARY 3D CEUS Generated Metric in Kidney Mass: Wash_In_intercept |
-18.30 | — |
| PRIMARY 3D CEUS Generated Metric in Kidney Mass: Wash_Out_Slope |
-0.93 | — |
| PRIMARY 3D CEUS Generated Metric in Kidney Mass: Wash_Out_Intercept |
125.84 | — |
| PRIMARY 3D CEUS Generated Metric in Kidney Mass: FR_a |
102.84 | — |
| PRIMARY 3D CEUS Generated Metric in Kidney Mass: FR_beta |
0.16 | — |
| PRIMARY 3D CEUS Generated Metric in Kidney Mass: Volume |
60.80 | — |
| PRIMARY 3D CEUS Generated Metric in Kidney Mass - Histopathologic Type vs. Wash_In_Slope |
7.61; 3.13; 4.23; 10.56; 12.28 | — |
| PRIMARY 3D CEUS Generated Metric in Kidney Mass - Histopathologic Type vs. Wash_In_intercept |
-11.02; -1.07; 31.12; -53.10; -122.88 | — |
| PRIMARY 3D CEUS Generated Metric in Kidney Mass - Histopathologic Type vs. Wash_Out_Slope |
7.62; 3.13; 4.23; 10.56; 12.3 | — |
| PRIMARY 3D CEUS Generated Metric in Kidney Mass - Histopathologic Type vs. Wash_Out_Intercept |
137.95; -0.43; 118.53; 139.01; 148.49 | — |
| PRIMARY 3D CEUS Generated Metric in Kidney Mass - Histopathologic Type vs. FR_a |
105.34; 0; 0; 0; 0 | — |
| PRIMARY 3D CEUS Generated Metric in Kidney Mass - Histopathologic Type vs. FR_beta |
0.10; 0; 0; 0; 0 | — |
| PRIMARY 3D CEUS Generated Metric in Kidney Mass - Histopathologic Type vs. Volume |
57.93; 260.78; 3.08; 4.77; 3.16 | — |
| SECONDARY 3D CEUS Generated Metric in Kidney Mass - Tumor Stage vs. Wash_In_Slope |
12.27; 6.91; 6.72; 9.32 | — |
| SECONDARY 3D CEUS Generated Metric in Kidney Mass - Tumor Stage vs. Wash_In_intercept |
-122.88; -9.36; -25.16; 8.55 | — |
| SECONDARY 3D CEUS Generated Metric in Kidney Mass - Tumor Stage vs. Wash_Out_Slope |
-0.90; -1.1; -0.51; -0.86 | — |
| SECONDARY 3D CEUS Generated Metric in Kidney Mass - Tumor Stage vs. Wash_Out_Intercept |
148.49; 139.36; 85.72; 154.1 | — |
| SECONDARY 3D CEUS Generated Metric in Kidney Mass - Tumor Stage vs. FR_a |
114.7; 102.8; 86.51; 115.9 | — |
| SECONDARY 3D CEUS Generated Metric in Kidney Mass - Tumor Stage vs. FR_beta |
0.11; 0.20; 0.13; 0.06 | — |
| SECONDARY 3D CEUS Generated Metric in Kidney Mass - Tumor Stage vs. Volume |
3.16; 15.42; 194.43; 70.64 | — |
| SECONDARY Pooled Kidney Mass Stage vs. 3D CEUS-generated Wash in Metrics |
7.31; 9.32 | — |
| SECONDARY Pooled Kidney Mass Stage Using 3D CEUS-generated Wash Out Metrics |
-0.94; -0.87 | — |
Summary
The purpose of this study is to determine if contrast-enhanced ultrasound can detect abnormal features of kidney lesions in patients with suspected kidney cancer with the same accuracy as conventional ultrasound and contrast-enhanced magnetic resonance imaging (MRI)
Eligibility Criteria
Inclusion Criteria
- A suspected diagnosis of kidney cancer with a solid or partially solid lesion and planned surgical nephrectomy within 3 months before surgery
- Able to provide informed consent
- Willing to comply with protocol requirements
- At least 18 years of age
Exclusion Criteria
- Critically ill or medically unstable or in an intensive care setting and whose critical course during a potential observation period would be unpredictable
- Known hypersensitivity to sulfur hexafluoride or to any component of perflutren lipid (Definity®) or sulfur hexafluoride (Lumason®)
- Right to left shunt, severe pulmonary hypertension (Pulmonary artery pressure >90mmHg), or adult respiratory distress syndrome
- Has any other medical condition or other circumstances that would significantly decrease the chances of obtaining reliable data or of achieving the study objectives
- Unstable cardiopulmonary disease including any of the following:
- Severe congestive heart failure (class IV in accordance with the classification of the New York Heart Association)
- Unstable angina
- Symptomatic arrhythmia (i.e. tachycardia, bradycardia, supraventricular tachycardia, ventricular fibrillation, ventricular tachycardia, atrial flutter or fibrillation)
- Myocardial infarction within 14 days prior to the date of proposed microbubble administration.
- Any woman who is pregnant or has reason to believe she is pregnant (the possibility of pregnancy has to be excluded by negative urine β-HCG results, obtained the same day as the CEUS, or on the basis of patient history, e.g.: tubal ligation, hysterectomy or a minimum of 1 year without menses)
- Obesity that limits obtainment of acceptable images
Data sourced from ClinicalTrials.gov (NCT04021238). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.