Kidney Cancer Clinical Trial
Official title:
Contrast-Enhanced Ultrasound for Kidney Cancer Subtyping and Staging
Verified date | October 2023 |
Source | UNC Lineberger Comprehensive Cancer Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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)
Status | Completed |
Enrollment | 25 |
Est. completion date | August 5, 2022 |
Est. primary completion date | August 5, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 99 Years |
Eligibility | 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 ß-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 |
Country | Name | City | State |
---|---|---|---|
United States | University of North Carolina at Chapel Hill | Chapel Hill | North Carolina |
Lead Sponsor | Collaborator |
---|---|
UNC Lineberger Comprehensive Cancer Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | 3D CEUS Generated Metric in Kidney Mass - Tumor Stage vs. Wash_In_Slope | 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 the curve. The association between tumor stage (Tumor stage 0,1,2,3) and CEUS-generated Wash_In_Slope parameter was studied.
Tumor staging is based on the size of the mass, spread to lymph nodes, and metastasis to distant sites according to American Joint Cancer Committee. All masses in this study were in stage 0, I, II or III (not stage IV). Stage 0 = cancer cell was not found on pathology. Stage I =tumors size =7 cm. Stage II = tumor size >7 cm. Stage III includes tumors that are growing into a major vein or tissue around the kidney with no spread to lymph nodes. |
Baseline- up to 3 minutes | |
Secondary | 3D CEUS Generated Metric in Kidney Mass - Tumor Stage vs. Wash_In_intercept | The association between tumor stage and CEUS-generated Wash_In_intercept parameter was studied. These values were generated by fitting the data to a linear equation. 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 that has a slope and an intercept. The values were negative because they were calculated (not measured).
Tumor staging is based on the size of the mass, spread to lymph nodes, and metastasis to distant sites according to the American Joint Cancer Committee. All masses in this study were in stage 0, I, II, or III (not stage IV). Stage 0 = cancer cell was not found on pathology. Stage I =tumors size =7 cm. Stage II = tumor size >7 cm. Stage III includes tumors that are growing into a major vein or tissue around the kidney with no spread to lymph nodes. |
Baseline- up to 3 minutes | |
Secondary | 3D CEUS Generated Metric in Kidney Mass - Tumor Stage vs. Wash_Out_Slope | The association between tumor stage (Tumor stage 0,1,2,3) and CEUS-generated Wash_Out_Slope parameter was studied. 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_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. Tumor staging is based on the size of the mass, spread to lymph nodes, and metastasis to distant sites according to the AJCC. All masses in this study were in stage 0, I, II, or III (not stage IV). Stage 0 = cancer cell was not found on pathology. Stage I =tumors size =7 cm. Stage II = tumor size >7 cm, Stage III includes tumors that are growing into a major vein or tissue around the kidney with no spread to lymph nodes. | Baseline- up to 3 minutes | |
Secondary | 3D CEUS Generated Metric in Kidney Mass - Tumor Stage vs. Wash_Out_Intercept | The association between tumor stage (Tumor stage 0,1,2,3) and CEUS-generated Wash_Out_Intercept parameter was studied. This metric indicates the intensity level of contrast at a 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 that has a slope and the intercept.
Tumor staging is based on the size of the mass, spread to lymph nodes, and metastasis to distant sites according to the American Joint Cancer Committee. All masses in this study were in stage 0, I, II, or III (not stage IV). Stage 0 = cancer cell was not found on pathology. Stage I =tumors size =7 cm. Stage II = tumor size >7 cm. Stage III includes tumors that are growing into a major vein or tissue around the kidney with no spread to lymph nodes. |
Baseline- up to 3 minutes | |
Secondary | 3D CEUS Generated Metric in Kidney Mass - Tumor Stage vs. FR_a | The association between tumor stage (Tumor stage 0,1,2,3) 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.
Tumor staging is based on the size of the mass, spread to lymph nodes, and metastasis to distant sites according to the American Joint Cancer Committee. All masses in this study were in stage 0, I, II or III (not stage IV). Stage 0 = cancer cell was not found on pathology. Stage I =tumors size =7 cm. Stage II = tumor size >7 cm. Stage III includes tumors that are growing into a major vein or tissue around the kidney with no spread to lymph nodes. |
Baseline- up to 3 minutes | |
Secondary | 3D CEUS Generated Metric in Kidney Mass - Tumor Stage vs. FR_beta | The association between tumor stage (Tumor stage 0,1,2,3) 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.
Tumor staging is based on the size of the mass, spread to lymph nodes, and metastasis to distant sites according to the American Joint Cancer Committee. All masses in this study were in stage 0, I, II, or III (not stage IV). Stage 0 = cancer cell was not found on pathology. Stage I =tumors size =7 cm. Stage II = tumor size >7 cm. Stage III includes tumors that are growing into a major vein or tissue around the kidney with no spread to lymph nodes. |
Baseline- up to 3 minutes | |
Secondary | 3D CEUS Generated Metric in Kidney Mass - Tumor Stage vs. Volume | The association between tumor stage (Tumor stage 0,1,2,3) and CEUS-generated volume was studied. The contrast-enhanced ultrasonogram (CEUS) volume was generated.
Tumor staging is based on the size of the mass, spread to lymph nodes, and metastasis to distant sites according to the American Joint Cancer Committee. All masses in this study were in stage 0, I, II or III (not stage IV). Stage 0 = cancer cell was not found on pathology. Stage I =tumors size =7 cm. Stage II = tumor size >7 cm. Stage III includes tumors that are growing into a major vein or tissue around the kidney with no spread to lymph nodes. |
Baseline- up to 3 minutes | |
Secondary | Pooled Kidney Mass Stage vs. 3D CEUS-generated Wash in Metrics | The association between pooled tumor stage (tumor stages 0,1,2 versus tumor stage 3) and CEUS-generated Wash_In_Slope parameter was studied. 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 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. Tumor staging is based on the size of the mass, spread to lymph nodes, and metastasis to distant sites according to the American Joint Cancer Committee. All masses in this study were in stage 0, I, II, or III (not stage IV). Stage 0 = cancer cell was not found on pathology. Stage I =tumors size =7 cm. Stage II = tumor size >7 cm. Stage III includes tumors that are growing into a major vein or tissue around the kidney with no spread to lymph nodes. | Baseline- up to 3 minutes | |
Secondary | Pooled Kidney Mass Stage Using 3D CEUS-generated Wash Out Metrics | The association between pooled tumor stage (tumor stages 0,1,2 versus tumor stage 3) and CEUS-generated Wash_Out_Slope parameter was studied. 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_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. Tumor staging is based on the size of the mass, spread to lymph nodes, and metastasis to distant sites according to the AJCC. All masses in this study were in stage 0, I, II, or III (not stage IV). Stage 0 = cancer cell was not found, Stage I = tumor size =7 cm, Stage II = tumor size >7 cm, Stage III includes tumors growing into a major vein or tissue, with no spread to lymph nodes. | Baseline- up to 3 minutes |
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