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 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: Active, not recruiting
• Conditions: Kidney Cancer; Renal Cell Carcinoma; Metastatic Renal Cell Carcinoma
• Intervention / Treatment: Diagnostic test: Doppler Ultrasound; Device: SIEMENS S3000 and Verasonics Vantage 256; Drug: Vascular Endothelial Growth Factor Receptor 2 tyrosine kinase inhibitor plus immune checkpoint inhibitor

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

Contacts and Locations

• Study Contact: Name: Christian R Hoerner; Phone Number: 650-721-3206; Email: hoerner@stanford.edu

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 metastatic 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
Experimental: Tyrosine kinase (TKI) inhibitor 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: Vascular Endothelial Growth Factor Receptor 2 tyrosine kinase inhibitor plus immune checkpoint inhibitor; Participants will receive less than 4 weeks of TKI treatment during the first 12 weeks. Plus immune checkpoint inhibitor (arm 1) or non-immune checkpoint inhibitor (arm 2); Other Names: TKI; VEGFR2
Experimental: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measure Initial Objective response	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. The results will be expressed as number without dispersion.	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Relative change in tumor burden compared to baseline	Relative change will be assessed as sum of all tumor diameters between treatment 'baseline' and first on-treatment response evaluation 8-16 weeks after start of treatment, using RECIST v1.1 for tumor diameter measurements, expressed as mean +/- standard deviation and median with interquartile range	12 weeks
Lesion response compared to baseline	Relative change in tumor diameter of a single lesion between treatment 'baseline' and first on-treatment response evaluation 8-16 weeks after start of treatment, using RECIST v1.1 for tumor diameter measurements, will be measured as mean +/- standard deviation and median with interquartile range.	12 weeks
Progression free survival (PFS)	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 (Estimated): December 1, 2024

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 (Estimated): February 15, 2024
• Last Update Submitted That Met QC Criteria: February 14, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Kidney Diseases; Urologic Diseases; Adenocarcinoma; Neoplasms, Glandular and Epithelial; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Kidney Neoplasms; Carcinoma, Renal Cell; Carcinoma; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Mitosis Modulators; Antineoplastic Agents, Immunological; Growth Substances; Protein Kinase Inhibitors; Immune Checkpoint Inhibitors; Endothelial Growth Factors; Mitogens; Tyrosine Protein Kinase Inhibitors
• 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