Serial Ultrasound in Metastatic Renal Cell Carcinoma (mRCC)

Stanford University22 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Kidney Cancer Renal Cell Carcinoma Metastatic Renal Cell Carcinoma

Interventions

Doppler UltrasoundDIAGNOSTIC_TEST

Power Doppler measurements will be made

SIEMENS S3000 and Verasonics Vantage 256DEVICE

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)DRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Stanford University School of Medicine

Stanford, California, United States

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 12 weeks

Secondary Outcomes

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

Time frame: 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

Time frame: 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.

Time frame: 12 weeks

Initial Per-Lesion Response Compared To Baseline - Second Participation

Data from ClinicalTrials.gov

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