Contrast-Enhanced Ultrasound for Kidney Cancer Subtyping and Staging

NCT04021238 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: LCCC1922
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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)

Conditions

Kidney Cancer

Outcome Measures

Primary Outcomes (14)

• 3D CEUS Generated Metrics in Kidney Mass: Wash_In_Slope

  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.

  Baseline- up to 3 minutes

• 3D CEUS Generated Metric in Kidney Mass: Wash_In_intercept

  A study-specific model was created to predict kidney tumor type. The contrast-enhanced ultrasonogram (CEUS) Wash\_In\_intercept parameter was generated. This metric indicates the intensity level prior to infusion of contrast. The intensity of the signal (the brightness of the image) values range between 0=black, and 255=white. This value was calculated using an equation for a line which has a slope and the intercept. The values were negative because they were calculated (not measured).

  Baseline- up to 3 minutes

• 3D CEUS Generated Metric in Kidney Mass: Wash_Out_Slope

  A study-specific model was created to predict kidney tumor type. The contrast-enhanced ultrasonogram (CEUS) Wash\_Out\_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) value range was between 0=black and 255=White. The wash Out slope decreases as the contrast agent clears the body/mass. Decreasing brightness is related to the slope of the curve. This results in a negative number. This value was generated by fitting the data to a linear equation.

  Baseline- up to 3 minutes

• 3D CEUS Generated Metric in Kidney Mass: Wash_Out_Intercept

  A study-specific model was created to predict kidney tumor type. The contrast-enhanced ultrasonogram (CEUS) Wash\_Out\_Intercept parameter was generated. This metric indicates the intensity level of contrast at a steady state of enhancement in the mass. The intensity of the signal (the brightness of the image) values range between 0=black, and 255=White. This value was calculated using an equation for a line that has a slope and an intercept.

  Baseline- up to 3 minutes

• 3D CEUS Generated Metric in Kidney Mass: FR_a

  A study-specific model was created to predict kidney tumor type. The contrast-enhanced ultrasonogram (CEUS) FR\_a parameter was generated. The intensity of the signal (the brightness of the image) value range is between 0=black, and 255=white. The intensity was plotted by time. FR\_a parameters were devised from an exponential fit. The exponential fit of the data provides the height of the curve.

  Baseline- up to 3 minutes

• 3D CEUS Generated Metric in Kidney Mass: FR_beta

  A study-specific model was created to predict kidney tumor type. The contrast-enhanced ultrasonogram (CEUS) FR\_beta parameter was generated. The intensity of the signal (the brightness of the image) value range is between 0=black, 255=White. The intensity was plotted by time. FR\_beta parameters were devised from an exponential fit. Exponential fit of the data provides the slope of the curve.

  Baseline- up to 3 minutes

• 3D CEUS Generated Metric in Kidney Mass: Volume

  A study-specific model was created to predict kidney tumor type. The contrast-enhanced ultrasonogram (CEUS) volume parameter was generated. The volumes were generated using the ellipsoid equation on the CEUS image of the kidney mass.

  Baseline- up to 3 minutes

• 3D CEUS Generated Metric in Kidney Mass - Histopathologic Type vs. Wash_In_Slope

  The association between tumor pathology type (Clear cell renal carcinoma (CCRCC) versus none (CCRCC) pathology) and CEUS-generated Wash\_In\_Slope parameter was studied. This metric indicates the change in contrast intensity with time in the mass using bolus imaging. 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 the curve.

  Baseline- up to 3 minutes

• 3D CEUS Generated Metric in Kidney Mass - Histopathologic Type vs. Wash_In_intercept

  The association between tumor pathology type (Clear cell renal carcinoma (CCRCC) versus none (CCRCC) pathology) and CEUS-generated Wash\_In\_intercept parameter was studied. This metric indicates the intensity level prior to infusion of contrast. The intensity of the signal (the brightness of the image) value range is between 0=black, and 255=White. This value was calculated using an equation for a line which has a slope and the intercept. The values were negative because they were calculated (not measured).

  Baseline- up to 3 minutes

• 3D CEUS Generated Metric in Kidney Mass - Histopathologic Type vs. Wash_Out_Slope

  The association between tumor pathology type (Clear cell renal carcinoma (CCRCC) versus none (CCRCC) pathology) and CEUS-generated Wash\_Out\_Slope parameter was studied. This metric indicates the change in contrast intensity with time in the mass using bolus imaging. The intensity of the signal (the brightness of the image) value range is between 0=black, and 255=White. Decreasing brightness is related to the slope of the curve. The Wash Out slope decreases as the contrast agent clears the body/mass. Decreasing brightness is related to the slope of the curve. This results in a negative number. This value was generated by fitting the data to a linear equation.

  Baseline- up to 3 minutes

• 3D CEUS Generated Metric in Kidney Mass - Histopathologic Type vs. Wash_Out_Intercept

  The association between tumor pathology type (Clear cell renal carcinoma (CCRCC) versus none (CCRCC) pathology) and CEUS-generated Wash\_Out\_Intercept parameter was studied. This metric indicates the intensity level of contrast at steady state of enhancement in the mass. The contrast-enhanced ultrasonogram (CEUS) Wash\_Out\_Intercept parameter was generated. The intensity of the signal (the brightness of the image) value range is between 0=black, and 255=White. This value was calculated using an equation for a line which has a slope and the intercept.

  Baseline- up to 3 minutes

• 3D CEUS Generated Metric in Kidney Mass - Histopathologic Type vs. FR_a

  The association between tumor pathology type (Clear cell renal carcinoma (CCRCC) versus none (CCRCC) pathology) and CEUS-generated FR\_a parameter was studied. The intensity of the signal (the brightness of the image) values range between 0=black, and 255=White. The intensity was plotted by time. FR\_a parameters were devised from an exponential fit. The exponential fit of the data provides the height of the curve.

  Baseline- up to 3 minutes

• 3D CEUS Generated Metric in Kidney Mass - Histopathologic Type vs. FR_beta

  The association between tumor pathology type (Clear cell renal carcinoma (CCRCC) versus none (CCRCC) pathology) and CEUS-generated FR\_ beta parameter was studied. The contrast-enhanced ultrasonogram (CEUS) FR\_beta parameter was generated. The intensity of the signal (the brightness of the image) values range between 0=black, and 255=White. The intensity was plotted by time. FR\_beta parameters were devised from an exponential fit. The exponential fit of the data provides the slope of the curve.

  Baseline- up to 3 minutes

• 3D CEUS Generated Metric in Kidney Mass - Histopathologic Type vs. Volume

  The association between tumor pathology type (Clear cell renal carcinoma (CCRCC) versus none (CCRCC) pathology) and CEUS-generated volume parameter was studied. The volumes were generated using the ellipsoid equation on the CEUS image of the kidney mass.

  Baseline- up to 3 minutes

Secondary Outcomes (9)

• 3D CEUS Generated Metric in Kidney Mass - Tumor Stage vs. Wash_In_Slope

  Baseline- up to 3 minutes

• 3D CEUS Generated Metric in Kidney Mass - Tumor Stage vs. Wash_In_intercept

  Baseline- up to 3 minutes

• 3D CEUS Generated Metric in Kidney Mass - Tumor Stage vs. Wash_Out_Slope

  Baseline- up to 3 minutes

• 3D CEUS Generated Metric in Kidney Mass - Tumor Stage vs. Wash_Out_Intercept

  Baseline- up to 3 minutes

• 3D CEUS Generated Metric in Kidney Mass - Tumor Stage vs. FR_a

  Baseline- up to 3 minutes

Study Arms (1)

Perflutren Lipid Microsphere or Lumason

EXPERIMENTAL

Patients with suspected kidney cancer and planned surgery will be imaged using contrast-enhanced ultrasound with either perflutren or Lumason.

Drug: Perflutren lipid microsphere; Drug: Sulfur hexafluoride lipid microspheres

Interventions

Perflutren lipid microsphere DRUG

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.

Also known as: Definity, Microbubble contrast agent

Perflutren Lipid Microsphere or Lumason

Sulfur hexafluoride lipid microspheres DRUG

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.

Also known as: Lumason

Perflutren Lipid Microsphere or Lumason

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• UNC Lineberger Comprehensive Cancer Center: lead

Study Sites (1)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

MeSH Terms

Conditions

Kidney Neoplasms

Interventions

perflutren

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Results Point of Contact

• Title: Director, Clinical Research, Department of Radiology
• Organization: UNC Chapel Hill

rad_research@med.unc.edu

919-966-4997

Study Officials

• Emily Chang, MD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2019
• First Posted: July 16, 2019
• Study Start: October 7, 2020
• Primary Completion: August 5, 2022
• Study Completion: August 5, 2022
• Last Updated: November 13, 2023
• Results First Posted: November 13, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)