Clinical trial · Interventional
Contrast-Enhanced Ultrasound for Kidney Cancer Subtyping and Staging
NCT04021238CI-TRIAL-00071267completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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)
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Kidney Cancer | Malignant Kidney Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Perflutren lipid microsphere | Drug | — | UNRESOLVED |
| Sulfur hexafluoride lipid microspheres | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Perflutren Lipid Microsphere or Lumason
- description
- Patients with suspected kidney cancer and planned surgery will be imaged using contrast-enhanced ultrasound with either perflutren or Lumason.
- interventionNames
- Drug: Perflutren lipid microsphere
- Drug: Sulfur hexafluoride lipid microspheres
Primary outcomes (14)
- measure
- 3D CEUS Generated Metrics in Kidney Mass: Wash_In_Slope
- timeFrame
- Baseline- up to 3 minutes
- description
- A study-specific model was created to predict kidney tumor type. The contrast-enhanced ultrasonogram (CEUS) Wash\_In\_Slope parameter was generated. This metric indicates the change in contrast with time in the mass using bolus imaging. Bolus imaging injects a small amount of contrast agent and monitors the contrast agent as it flows in (wash-in) and out (wash-out) of the body/mass. The intensity of the signal (the brightness of the image) is plotted over time to generate the time-intensity curve. The intensity of the signal (the brightness of the image) values range between 0=black, and 255=White.The Wash\_In\_Slope increases as the contrast agent is introduced to the body/mass. This value was generated by fitting the data to a linear equation. Increasing brightness is related to the slope of curve.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.