Serial Ultrasound in Metastatic Renal Cell Carcinoma (mRCC)

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-05

Study Completion Date

2023-11-30

Brief Summary

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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

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Detailed Description

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Conditions

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Kidney Cancer Renal Cell Carcinoma Metastatic Renal Cell Carcinoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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)

Group Type ACTIVE_COMPARATOR

Doppler Ultrasound

Intervention Type DIAGNOSTIC_TEST

Power Doppler measurements will be made

SIEMENS S3000 and Verasonics Vantage 256

Intervention Type DEVICE

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)

Intervention Type DRUG

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

Non-ICI therapy

Patients are planned to be treated with non-ICI therapy

Group Type ACTIVE_COMPARATOR

Doppler Ultrasound

Intervention Type DIAGNOSTIC_TEST

Power Doppler measurements will be made

SIEMENS S3000 and Verasonics Vantage 256

Intervention Type DEVICE

Vantage 256 used for power Doppler ultrasound, manufactured by Verasonics

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

Intervention Type DRUG

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

Interventions

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Doppler Ultrasound

Power Doppler measurements will be made

Intervention Type DIAGNOSTIC_TEST

SIEMENS S3000 and Verasonics Vantage 256

Vantage 256 used for power Doppler ultrasound, manufactured by Verasonics

Intervention Type DEVICE

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).

Intervention Type DRUG

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

Intervention Type DRUG

Other Intervention Names

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VEGFR2 TKI ICI

Eligibility Criteria

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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.

* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No