Serial Ultrasound in Metastatic Renal Cell Carcinoma (mRCC)

Early Therapeutic Monitoring of Response to Therapy With Serial Ultrasound in Metastatic Renal Cell Carcinoma (mRCC)

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

Study Overview

• Status: Completed
• Conditions: Kidney Cancer; Renal Cell Carcinoma; Metastatic Renal Cell Carcinoma
• Intervention / Treatment: 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

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Stanford, California, United States, 94305
      • Stanford University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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)	Diagnostic test: Doppler Ultrasound; Power Doppler measurements will be made; Device: SIEMENS S3000 and Verasonics Vantage 256; Vantage 256 used for power Doppler ultrasound, manufactured by Verasonics; Drug: Standard-of-care Vascular Endothelial Growth Factor Receptor 2 (VEGFR2) 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).; Other Names: TKI; VEGFR2; ICI
Active Comparator: Non-ICI therapy; Patients are planned to be treated with non-ICI therapy	Diagnostic test: Doppler Ultrasound; Power Doppler measurements will be made; Device: SIEMENS S3000 and Verasonics Vantage 256; Vantage 256 used for power Doppler ultrasound, manufactured by Verasonics; Drug: Standard-of-care non-immune checkpoint inhibitor (ICI) such as single-agent VEGFR2 TKI; Standard-of-care non-immune checkpoint inhibitor (ICI) such as single-agent VEGFR2 TKI

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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.	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.	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).	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.	12 months

Collaborators and Investigators

• Sponsor: Stanford University
• Collaborators: National Institutes of Health (NIH)
• Investigators: Principal Investigator: Alice C Fan, MD, Stanford University; Principal Investigator: Jeremy Dahl, PhD, Stanford University

Study record dates

Study Major Dates

• Study Start (Actual): December 5, 2020
• Primary Completion (Actual): November 30, 2023
• Study Completion (Actual): November 30, 2023

Study Registration Dates

• First Submitted: July 29, 2020
• First Submitted That Met QC Criteria: August 7, 2020
• First Posted (Actual): August 11, 2020

Study Record Updates

• Last Update Posted (Actual): July 25, 2025
• Last Update Submitted That Met QC Criteria: July 23, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Adenocarcinoma; Urologic Neoplasms; Carcinoma; Carcinoma, Renal Cell; Kidney Neoplasms; Antineoplastic Agents, Immunological; Antineoplastic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protein Kinase Inhibitors; Mitosis Modulators; Growth Substances; Immune Checkpoint Inhibitors; Tyrosine Kinase Inhibitors; Endothelial Growth Factors; Mitogens
• Other Study ID Numbers: IRB-55742; RENAL0042 (Other Identifier: OnCore); NCI-2021-02327 (Registry Identifier: CTRP); 1R03CA25277601 (Other Grant/Funding Number: NIH)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes