An interventional study of Doppler Ultrasound and SIEMENS S3000 and Verasonics Vantage 256 in Kidney Cancer, Renal Cell Carcinoma and Metastatic Renal Cell Carcinoma, sponsored by Stanford University. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-07-25.
Sponsored by Stanford University · Not applicable, Interventional, and Diagnostic
To assess whether changes in quantitative tumor perfusion parameters after 3 or 6 weeks of treatment, as measured by power Doppler ultrasound, can predict initial objective response, defined by current standard-of-care, to therapy at 12 weeks after start of treatment
956 studies on the registry are indexed under Kidney Neoplasms; 210 are open to participants now.
This study's enrollment of 22 is below the median of 43 across 650 interventional studies indexed under Kidney Neoplasms.
Browse Kidney Neoplasms studies →Stanford University is the lead sponsor of 2,117 studies on the registry; 425 are open to participants now.
Of its 259 completed or terminated interventional studies of FDA-regulated products, 197 (76%) have results posted.
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Specific inclusion criteria:
Exclusion Criteria:
-Any comorbid condition that, in the opinion of the treating provider or the Protocol Directors, compromises the participant's ability to participate in the study
Patients are planned to be treated with vascular endothelial growth factor 2 (VEGFR2) tyrosine kinase inhibitor (TKI) plus immune checkpoint inhibitor (ICI)
Diagnostic Test: Doppler Ultrasound · Device: SIEMENS S3000 and Verasonics Vantage 256 · Drug: Standard-of-care Vascular Endothelial Growth Factor Receptor 2 (VEGFR2) tyrosine kinase inhibitor (TKI) plus immune checkpoint inhibitor (ICI)
Patients are planned to be treated with non-ICI therapy
Diagnostic Test: Doppler Ultrasound · Device: SIEMENS S3000 and Verasonics Vantage 256 · Drug: Standard-of-care non-immune checkpoint inhibitor (ICI) such as single-agent VEGFR2 TKI
Power Doppler measurements will be made
Vantage 256 used for power Doppler ultrasound, manufactured by Verasonics
Standard-of-care Vascular Endothelial Growth Factor Receptor 2 (VEGFR2) tyrosine kinase inhibitor (TKI) plus immune checkpoint inhibitor (ICI).
Also known as: VEGFR2, TKI, ICI
Standard-of-care non-immune checkpoint inhibitor (ICI) such as single-agent VEGFR2 TKI
Initial Objective Response- First Participation
Initial objective response was defined as having either Complete Response (CR) or Partial Response (PR) per RECIST v1.1 at first on-treatment response evaluation 8-16 weeks after initiating treatment.
Time frame: 12 weeks
Initial Objective Response- Second Participation
Initial objective response is defined as having either Complete Response (CR) or Partial Response (PR) per RECIST v1.1 at first on-treatment response evaluation 8-16 weeks after initiating treatment.
Time frame: 12 weeks
Initial Relative Change in Tumor Burden Compared to Baseline - First Participation
Tumor burden was assessed as the sum of all tumor diameters at baseline compared to the first on-treatment response evaluation (8-16 weeks after the start of treatment) using RECIST v1.1 criteria
Time frame: 8-16 weeks after the start of treatment
Initial Relative Change in Tumor Burden Compared to Baseline - Second Participation
Tumor burden was assessed as the sum of all tumor diameters at baseline compared to the first on-treatment response evaluation (8-16 weeks after the start of treatment) using RECIST v1.1 criteria
Time frame: 8-16 weeks after the start of treatment
Initial Per-Lesion Response Compared To Baseline - First Participation
The relative change in tumor diameter of a single lesion between treatment 'baseline' and the first on-treatment response evaluation 8-16 weeks after the start of treatment, using RECIST v1.1 for tumor diameter measurements. This was measured as percent change and reported as mean ± standard deviation.
Time frame: 12 weeks
Initial Per-Lesion Response Compared To Baseline - Second Participation
The relative change in tumor diameter of a single lesion between treatment 'baseline' and the first on-treatment response evaluation 8-16 weeks after the start of treatment, using RECIST v1.1 for tumor diameter measurements. This was measured as percent change and reported as mean ± standard deviation.
Time frame: 12 weeks
12-month Progression Free Survival (PFS)- First Participation
PFS was defined as not having experienced any progressive disease (PD) per RECIST v1.1 within the first 12 months after initiating treatment (day 1 will be treatment start date).
Time frame: 12 months
12-month Progression Free Survival (PFS)- Second Participation
PFS is defined as not having experienced any progressive disease (PD) per RECIST v1.1 within the first 12 months after initiating treatment (day 1 will be treatment start date), as a number and proportion without dispersion.
Time frame: 12 months
| Milestone | ARM 1: Tyrosine Kinase Inhibitor (TKI) Plus Immune Checkpoint Inhibitor (ICI) | ARM 2: Non-ICI Therapy | ARM 3: Enrolled Consecutively in Both Arms |
|---|---|---|---|
| Started | 12 | 5 | 2 |
| Completed | 10 | 5 | 2 |
| Not completed | 2 | 0 | 0 |
Initial objective response was defined as having either Complete Response (CR) or Partial Response (PR) per RECIST v1.1 at first on-treatment response evaluation 8-16 weeks after initiating treatment.
| Participants | ARM 1: Tyrosine Kinase Inhibitor (TKI) Plus Immune Checkpoint Inhibitor (ICI) | ARM 2: Non-ICI Therapy |
|---|---|---|
| Yes (CR or PR) | 5 | 1 |
| No (SD or PD) | 7 | 4 |
Initial objective response is defined as having either Complete Response (CR) or Partial Response (PR) per RECIST v1.1 at first on-treatment response evaluation 8-16 weeks after initiating treatment.
| Participants | ARM 3: Enrolled Consecutively in Both Arms |
|---|---|
| Yes (CR or PR) | 0 |
| No (SD or PD) | 1 |
Tumor burden was assessed as the sum of all tumor diameters at baseline compared to the first on-treatment response evaluation (8-16 weeks after the start of treatment) using RECIST v1.1 criteria
| Percentage change from baseline | ARM 1: Tyrosine Kinase Inhibitor (TKI) Plus Immune Checkpoint Inhibitor (ICI) | ARM 2: Non-ICI Therapy |
|---|---|---|
| Initial Relative Change in Tumor Burden Compared to Baseline - First Participation | -16.0 ± 70.3 | 43.7 ± 94.8 |
Tumor burden was assessed as the sum of all tumor diameters at baseline compared to the first on-treatment response evaluation (8-16 weeks after the start of treatment) using RECIST v1.1 criteria
| Percentage change from baseline | ARM 3: Enrolled Consecutively in Both Arms |
|---|---|
| Initial Relative Change in Tumor Burden Compared to Baseline - Second Participation | -20.7 ± 0 |
The relative change in tumor diameter of a single lesion between treatment 'baseline' and the first on-treatment response evaluation 8-16 weeks after the start of treatment, using RECIST v1.1 for tumor diameter measurements. This was measured as percent change and reported as mean ± standard deviation.
| Percentage change from baseline | ARM 1: Tyrosine Kinase Inhibitor (TKI) Plus Immune Checkpoint Inhibitor (ICI) | ARM 2: Non-ICI Therapy |
|---|---|---|
| Initial Per-Lesion Response Compared To Baseline - First Participation | -28.0 ± 23.0 | -4.6 ± 19.0 |
The relative change in tumor diameter of a single lesion between treatment 'baseline' and the first on-treatment response evaluation 8-16 weeks after the start of treatment, using RECIST v1.1 for tumor diameter measurements. This was measured as percent change and reported as mean ± standard deviation.
| Percentage change from baseline | ARM 3: Enrolled Consecutively in Both Arms |
|---|---|
| Initial Per-Lesion Response Compared To Baseline - Second Participation | -6.3 ± 18.7 |
PFS was defined as not having experienced any progressive disease (PD) per RECIST v1.1 within the first 12 months after initiating treatment (day 1 will be treatment start date).
| Participants | ARM 1: Tyrosine Kinase Inhibitor (TKI) Plus Immune Checkpoint Inhibitor (ICI) | ARM 2: Non-ICI Therapy |
|---|---|---|
| Yes (No PD and no death experienced) | 7 | 3 |
| No (PD or death experienced) | 4 | 2 |
PFS is defined as not having experienced any progressive disease (PD) per RECIST v1.1 within the first 12 months after initiating treatment (day 1 will be treatment start date), as a number and proportion without dispersion.
| Participants | ARM 3: Enrolled Consecutively in Both Arms |
|---|---|
| Yes (No PD and no death experienced) | 0 |
| No (PD or death experienced) | 1 |
Collected over First study ultrasound exam through 12 weeks after starting treatment.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| ARM 1: Tyrosine Kinase Inhibitor (TKI) Plus Immune Checkpoint Inhibitor (ICI) | 1/12 (8.3%) | 0/12 (0%) | 2/12 (16.7%) |
| ARM 2: Non-ICI Therapy | 0/5 (0%) | 0/5 (0%) | 0/5 (0%) |
| ARM 3: Enrolled Consecutively in Both Arms | 0/2 (0%) | 0/2 (0%) | 0/2 (0%) |
| Event | ARM 1: Tyrosine Kinase Inhibitor (TKI) Plus Immune Checkpoint Inhibitor (ICI) | ARM 2: Non-ICI Therapy | ARM 3: Enrolled Consecutively in Both Arms |
|---|---|---|---|
| Abdominal PainGastrointestinal disorders | 2/12 | 0/5 | 0/2 |
| Age, Categorical(Participants) | ARM 1: Tyrosine Kinase Inhibitor (TKI) Plus Immune Checkpoint Inhibitor (ICI) | ARM 2: Non-ICI Therapy | ARM 3: Enrolled Consecutively in Both Arms | Total |
|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 9 | 1 | 2 | 12 |
| >=65 years | 3 | 4 | 0 | 7 |
| Sex: Female, Male(Participants) | ARM 1: Tyrosine Kinase Inhibitor (TKI) Plus Immune Checkpoint Inhibitor (ICI) | ARM 2: Non-ICI Therapy | ARM 3: Enrolled Consecutively in Both Arms | Total |
|---|---|---|---|---|
| Female | 1 | 1 | 1 | 3 |
| Male | 11 | 4 | 1 | 16 |
| Ethnicity (NIH/OMB)(Participants) | ARM 1: Tyrosine Kinase Inhibitor (TKI) Plus Immune Checkpoint Inhibitor (ICI) | ARM 2: Non-ICI Therapy | ARM 3: Enrolled Consecutively in Both Arms | Total |
|---|---|---|---|---|
| Hispanic or Latino | 4 | 1 | 2 | 7 |
| Not Hispanic or Latino | 8 | 4 | 0 | 12 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | ARM 1: Tyrosine Kinase Inhibitor (TKI) Plus Immune Checkpoint Inhibitor (ICI) | ARM 2: Non-ICI Therapy | ARM 3: Enrolled Consecutively in Both Arms | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 1 | 2 | 0 | 3 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 | 0 |
| White | 6 | 3 | 1 | 10 |
| More than one race | 1 | 0 | 0 | 1 |
| Unknown or Not Reported | 4 | 0 | 1 | 5 |
| Region of Enrollment(participants) | ARM 1: Tyrosine Kinase Inhibitor (TKI) Plus Immune Checkpoint Inhibitor (ICI) | ARM 2: Non-ICI Therapy | ARM 3: Enrolled Consecutively in Both Arms | Total |
|---|---|---|---|---|
| United States | 12 | 5 | 2 | 19 |
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