Serial Ultrasound in Metastatic Renal Cell Carcinoma (mRCC)

Not Applicable

Active, not recruiting

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

• Registration Number: NCT04508725
• Lead Sponsor: Stanford University

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-07-29
• Study First Submitted QC: 2020-08-07
• Study First Posted: 2020-08-11
• Study Start: 2020-12-05
• Primary Completion: 2023-11-30
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-14
• Last Update Posted: 2024-02-15
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 22

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Tyrosine kinase (TKI) inhibitor plus immune checkpoint inhibitor (ICI)	SIEMENS S3000 and Verasonics Vantage 256	Patients are planned to be treated with vascular endothelial growth factor 2 (VEGFR2) tyrosine kinase inhibitor (TKI) plus immune checkpoint inhibitor (ICI)
Tyrosine kinase (TKI) inhibitor plus immune checkpoint inhibitor (ICI)	Vascular Endothelial Growth Factor Receptor 2 tyrosine kinase inhibitor plus immune checkpoint inhibitor	Patients are planned to be treated with vascular endothelial growth factor 2 (VEGFR2) tyrosine kinase inhibitor (TKI) plus immune checkpoint inhibitor (ICI)
Non-ICI therapy	Doppler Ultrasound	Patients are planned to be treated with non-ICI therapy
Non-ICI therapy	SIEMENS S3000 and Verasonics Vantage 256	Patients are planned to be treated with non-ICI therapy
Tyrosine kinase (TKI) inhibitor plus immune checkpoint inhibitor (ICI)	Doppler Ultrasound	Patients are planned to be treated with vascular endothelial growth factor 2 (VEGFR2) tyrosine kinase inhibitor (TKI) plus immune checkpoint inhibitor (ICI)

Primary Outcome Measures

Name	Time	Method
Measure Initial Objective response	12 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Relative change in tumor burden compared to baseline	12 weeks	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
Lesion response compared to baseline	12 weeks	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.
Progression free survival (PFS)	12 months	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.

Trial Locations

Locations (1)

Stanford University School of Medicine; 🇺🇸 Stanford, California, United States