Serial Ultrasound in Metastatic Renal Cell Carcinoma (mRCC)

Stanford University

Status: Completed

Conditions: Metastatic Renal Cell Carcinoma; Kidney Cancer; Renal Cell Carcinoma

Treatments: Diagnostic Test: Doppler Ultrasound; Drug: Standard-of-care Vascular Endothelial Growth Factor Receptor 2 (VEGFR2) tyrosine kinase inhibitor (TKI) plus immune checkpoint inhibitor (ICI); Device: SIEMENS S3000 and Verasonics Vantage 256; Drug: Standard-of-care non-immune checkpoint inhibitor (ICI) such as single-agent VEGFR2 TKI

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04508725

IRB-55742

NCI-2021-02327 (Registry Identifier)

RENAL0042 (Other Identifier)

1R03CA25277601 (Other Grant/Funding Number)

Details and patient eligibility

About

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

Enrollment: 22 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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22 participants in 2 patient groups

Tyrosine kinase inhibitor (TKI) plus immune checkpoint inhibitor (ICI)

Active Comparator group

Description:

Patients are planned to be treated with vascular endothelial growth factor 2 (VEGFR2) tyrosine kinase inhibitor (TKI) plus immune checkpoint inhibitor (ICI)

Treatment:

Drug: Standard-of-care Vascular Endothelial Growth Factor Receptor 2 (VEGFR2) tyrosine kinase inhibitor (TKI) plus immune checkpoint inhibitor (ICI)

Device: SIEMENS S3000 and Verasonics Vantage 256

Diagnostic Test: Doppler Ultrasound

Non-ICI therapy

Active Comparator group

Description:

Patients are planned to be treated with non-ICI therapy

Treatment:

Drug: Standard-of-care non-immune checkpoint inhibitor (ICI) such as single-agent VEGFR2 TKI

Device: SIEMENS S3000 and Verasonics Vantage 256

Diagnostic Test: Doppler Ultrasound