Neoplasms

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Carcinoma

Carcinoma, Renal Cell

Kidney Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Kidney Diseases

Urologic Diseases

Male Urogenital Diseases

Renal Cell Carcinoma

Clear Cell Renal Cell Carcinoma

Antineoplastic Agents

All Drugs and Chemicals

Amino Acids

Immune Checkpoint Inhibitors

Endothelial Growth Factors

Mitogens

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Antineoplastic Agents, Immunological

Tyrosine

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

Patients are planned to be treated with non-ICI therapy

Doppler Ultrasound

Vantage 256 used for power doppler ultrasound, manufactured by Verasonics

SIEMENS S3000 and Verasonics Vantage 256

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)

Vascular Endothelial Growth Factor Receptor 2 tyrosine kinase inhibitor plus immune checkpoint inhibitor

Alice C Fan, MD

Jeremy Dahl, PhD

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

Serial Ultrasound in Metastatic Renal Cell Carcinoma (mRCC)

Early Therapeutic Monitoring of Response to Therapy With Serial Ultrasound in Metastatic Renal Cell Carcinoma (mRCC)

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.

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

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.

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.

National Institutes of Health (NIH)

Stanford University

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Serial Ultrasound in Metastatic Renal Cell Carcinoma (mRCC)	NCT04508725	Kidney Cancer Renal Cell Carc... Metastatic Rena...	Doppler Ultraso... SIEMENS S3000 a... Vascular Endoth...	18 Years -	Stanford University
Serial Ultrasound in Metastatic Renal Cell Carcinoma (mRCC)	NCT04508725	Kidney Cancer Renal Cell Carc... Metastatic Rena...	Doppler Ultraso... SIEMENS S3000 a... Vascular Endoth...	18 Years -	Stanford University

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