Serial Ultrasound in Metastatic Renal Cell Carcinoma (mRCC)

Not Applicable

Completed

• Conditions: Kidney Cancer; Renal Cell Carcinoma; Metastatic Renal Cell Carcinoma
• Interventions: 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); Drug: Standard-of-care non-immune checkpoint inhibitor (ICI) such as single-agent VEGFR2 TKI

• Registration Number: NCT04508725
• Lead Sponsor: Stanford University

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-07-29
• Study First Submitted QC: 2020-08-07
• Study First Posted: 2020-08-11
• Study Start: 2020-12-05
• Primary Completion: 2023-11-30
• Study Completion: 2023-11-30
• Results First Submitted: 2024-11-30
• Status Verified: 2025-07
• Results First Submitted QC: 2025-07-23
• Last Update Submitted: 2025-07-23
• Results First Posted: 2025-07-25
• Last Update Posted: 2025-07-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

• 18 years of age or older
• Pathology-confirmed diagnosis of Renal cell carcinoma (RCC)
• At least one tumor lesion greater than 1 cm in diameter, amenable to ultrasound imaging
• Written informed consent.

Specific inclusion criteria:

• Arm 1: planned to be treated with combination of VEGFR2 tyrosine kinase inhibitor (TKI) plus immune checkpoint inhibitor (ICI)
• Arm 2: planned to be treated with non-ICI therapy

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Tyrosine kinase inhibitor (TKI) plus immune checkpoint inhibitor (ICI)	Doppler Ultrasound	Patients are planned to be treated with vascular endothelial growth factor 2 (VEGFR2) tyrosine kinase inhibitor (TKI) plus immune checkpoint inhibitor (ICI)
Tyrosine kinase inhibitor (TKI) plus immune checkpoint inhibitor (ICI)	SIEMENS S3000 and Verasonics Vantage 256	Patients are planned to be treated with vascular endothelial growth factor 2 (VEGFR2) tyrosine kinase inhibitor (TKI) plus immune checkpoint inhibitor (ICI)
Tyrosine kinase inhibitor (TKI) plus immune checkpoint inhibitor (ICI)	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 vascular endothelial growth factor 2 (VEGFR2) tyrosine kinase inhibitor (TKI) plus immune checkpoint inhibitor (ICI)
Non-ICI therapy	Doppler Ultrasound	Patients are planned to be treated with non-ICI therapy
Non-ICI therapy	SIEMENS S3000 and Verasonics Vantage 256	Patients are planned to be treated with non-ICI therapy
Non-ICI therapy	Standard-of-care non-immune checkpoint inhibitor (ICI) such as single-agent VEGFR2 TKI	Patients are planned to be treated with non-ICI therapy

Primary Outcome Measures

Name	Time	Method
Initial Objective Response- First Participation	12 weeks	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.
Initial Objective Response- Second Participation	12 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Initial Relative Change in Tumor Burden Compared to Baseline - First Participation	8-16 weeks after the start of treatment	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
Initial Relative Change in Tumor Burden Compared to Baseline - Second Participation	8-16 weeks after the start of treatment	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
Initial Per-Lesion Response Compared To Baseline - First Participation	12 weeks	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.
Initial Per-Lesion Response Compared To Baseline - Second Participation	12 weeks	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.
12-month Progression Free Survival (PFS)- First Participation	12 months	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).
12-month Progression Free Survival (PFS)- Second Participation	12 months	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.

Trial Locations

Locations (1)

Stanford University School of Medicine; 🇺🇸 Stanford, California, United States