NCT04021238

Contrast-Enhanced Ultrasound for Kidney Cancer Subtyping and Staging

Completed Phase 2 Results posted Last updated 13 November 2023

What this trial tests

Phase 2 trial testing Perflutren lipid microsphere in Kidney Cancer in 25 participants. Completed in 5 August 2022.

Timeline

7 October 2020

Primary endpoint
5 August 2022

5 August 2022

Quick facts

Lead sponsor	UNC Lineberger Comprehensive Cancer Center
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	diagnostic
Enrollment	25
Start date	7 October 2020
Primary completion	5 August 2022
Estimated completion	5 August 2022
Sites	1 location across United States

Drugs / interventions tested

• Perflutren lipid microsphere — full drug profile →
• Sulfur hexafluoride lipid microspheres — full drug profile →

Conditions studied

• Kidney Cancer — all drugs for Kidney Cancer →

Sponsor

UNC Lineberger Comprehensive Cancer Center — full company profile →

Who can join

Adults 18 to 99, any sex, with Kidney Cancer. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

3D CEUS Generated Metrics in Kidney Mass: Wash_In_Slope Primary · Baseline- up to 3 minutes

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=W

Group	Value	95% CI
CEUS Imaging Parameters	7.60	3.13 – 12.28

3D CEUS Generated Metric in Kidney Mass: Wash_In_intercept Primary · Baseline- up to 3 minutes

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).

Group	Value	95% CI
CEUS Imaging Parameters	-18.30	-149.6 – 62.11

3D CEUS Generated Metric in Kidney Mass: Wash_Out_Slope Primary · Baseline- up to 3 minutes

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 25

Group	Value	95% CI
CEUS Imaging Parameters	-0.93	-2.09 – -0.41

3D CEUS Generated Metric in Kidney Mass: Wash_Out_Intercept Primary · Baseline- up to 3 minutes

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.

Group	Value	95% CI
CEUS Imaging Parameters	125.84	43.28 – 199.71

3D CEUS Generated Metric in Kidney Mass: FR_a Primary · Baseline- up to 3 minutes

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.

Group	Value	95% CI
CEUS Imaging Parameters	102.84	61.01 – 152.8

3D CEUS Generated Metric in Kidney Mass: FR_beta Primary · Baseline- up to 3 minutes

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.

Group	Value	95% CI
CEUS Imaging Parameters	0.16	0.03 – 0.77

3D CEUS Generated Metric in Kidney Mass: Volume Primary · Baseline- up to 3 minutes

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.

Group	Value	95% CI
CEUS Imaging Parameters	60.80	3.08 – 271.97

3D CEUS Generated Metric in Kidney Mass - Histopathologic Type vs. Wash_In_Slope Primary · Baseline- up to 3 minutes

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.

Group	Value	95% CI
Clear Cell Renal Carcinoma	7.61	± 2.33
Papillary Carcinoma	3.13	± NA
Clear Cell Papillary	4.23	± NA
Chromophobe	10.56	± NA
Other	12.28	± NA

3D CEUS Generated Metric in Kidney Mass - Histopathologic Type vs. Wash_In_intercept Primary · Baseline- up to 3 minutes

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).

Group	Value	95% CI
Clear Cell Renal Carcinoma	-11.02	± 58.96
Papillary Carcinoma	-1.07	± NA
Clear Cell Papillary	31.12	± NA
Chromophobe	-53.10	± NA
Other	-122.88	± NA

3D CEUS Generated Metric in Kidney Mass - Histopathologic Type vs. Wash_Out_Slope Primary · Baseline- up to 3 minutes

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

Group	Value	95% CI
Clear Cell Renal Carcinoma	7.62	± 2.33
Papillary Carcinoma	3.13	± NA
Clear Cell Papillary	4.23	± NA
Chromophobe	10.56	± NA
Other	12.3	± NA

3D CEUS Generated Metric in Kidney Mass - Histopathologic Type vs. Wash_Out_Intercept Primary · Baseline- up to 3 minutes

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.

Group	Value	95% CI
Clear Cell Renal Carcinoma	137.95	± 36.88
Papillary Carcinoma	-0.43	± NA
Clear Cell Papillary	118.53	± NA
Chromophobe	139.01	± NA
Other	148.49	± NA

3D CEUS Generated Metric in Kidney Mass - Histopathologic Type vs. FR_a Primary · Baseline- up to 3 minutes

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.

Group	Value	95% CI
Clear Cell Renal Carcinoma	105.34	± 27.09
Papillary Carcinoma	0	± NA
Clear Cell Papillary	0	± NA
Chromophobe	0	± NA
Other	0	± NA

Sponsor's own description

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)

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.