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Phase 2 N=24 Diagnostic

Contrast-Enhanced Ultrasound for Kidney Cancer Subtyping and Staging

Kidney Cancer

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

OutcomeResultp-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
View full record on ClinicalTrials.gov →

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.

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