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Completed

NCT Number: NCT04508725

Serial Ultrasound in Metastatic Renal Cell Carcinoma (mRCC)

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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Key information

Conditions

Kidney Cancer Adenocarcinoma Carcinoma Carcinoma, Renal Cell Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Neoplasms Male Urogenital Diseases Metastatic Renal Cell Carcinoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Renal Cell Carcinoma Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanford University School of Medicine

Stanford, California, 94305, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Doppler Ultrasound

Diagnostic Test

Power Doppler measurements will be made

SIEMENS S3000 and Verasonics Vantage 256

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)

Drug

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

Other names: VEGFR2, TKI, ICI

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

Drug

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

Primary outcomes

  1. Initial Objective Response- First Participation

    Time frame: 12 weeks

    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.

  2. Initial Objective Response- Second Participation

    Time frame: 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.

Secondary outcomes

  1. Initial Relative Change in Tumor Burden Compared to Baseline - First Participation

    Time frame: 8-16 weeks after the start of treatment

    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

  2. Initial Relative Change in Tumor Burden Compared to Baseline - Second Participation

    Time frame: 8-16 weeks after the start of treatment

    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

  3. Initial Per-Lesion Response Compared To Baseline - First Participation

    Time frame: 12 weeks

    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.

  4. Initial Per-Lesion Response Compared To Baseline - Second Participation

    Time frame: 12 weeks

    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.

  5. 12-month Progression Free Survival (PFS)- First Participation

    Time frame: 12 months

    PFS was 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).

  6. 12-month Progression Free Survival (PFS)- Second Participation

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Collaborators

  • National Institutes of Health (NIH)

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Aug 11, 2020
Registry last updated
Jul 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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