NCT04508725

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 29, 2020

Completed
13 days until next milestone

First Posted

Study publicly available on registry

August 11, 2020

Completed
4 months until next milestone

Study Start

First participant enrolled

December 5, 2020

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2023

Completed
1.7 years until next milestone

Results Posted

Study results publicly available

July 25, 2025

Completed
Last Updated

July 25, 2025

Status Verified

July 1, 2025

Enrollment Period

3 years

First QC Date

July 29, 2020

Results QC Date

November 30, 2024

Last Update Submit

July 23, 2025

Conditions

Kidney CancerRenal Cell CarcinomaMetastatic Renal Cell Carcinoma

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    12 weeks

Secondary Outcomes (6)

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

    8-16 weeks after the start of treatment

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

    8-16 weeks after the start of treatment

  • Initial Per-Lesion Response Compared To Baseline - First Participation

    12 weeks

  • Initial Per-Lesion Response Compared To Baseline - Second Participation

    12 weeks

  • 12-month Progression Free Survival (PFS)- First Participation

    12 months

  • +1 more secondary outcomes

Study Arms (2)

Tyrosine kinase inhibitor (TKI) plus immune checkpoint inhibitor (ICI)

ACTIVE COMPARATOR

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

Diagnostic Test: Doppler UltrasoundDevice: SIEMENS S3000 and Verasonics Vantage 256Drug: Standard-of-care Vascular Endothelial Growth Factor Receptor 2 (VEGFR2) tyrosine kinase inhibitor (TKI) plus immune checkpoint inhibitor (ICI)

Non-ICI therapy

ACTIVE COMPARATOR

Patients are planned to be treated with non-ICI therapy

Diagnostic Test: Doppler UltrasoundDevice: SIEMENS S3000 and Verasonics Vantage 256Drug: Standard-of-care non-immune checkpoint inhibitor (ICI) such as single-agent VEGFR2 TKI

Interventions

Doppler UltrasoundDIAGNOSTIC_TEST

Power Doppler measurements will be made

Non-ICI therapyTyrosine kinase inhibitor (TKI) plus immune checkpoint inhibitor (ICI)
SIEMENS S3000 and Verasonics Vantage 256DEVICE

Vantage 256 used for power Doppler ultrasound, manufactured by Verasonics

Non-ICI therapyTyrosine 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)DRUG

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

Also known as: VEGFR2, TKI, ICI
Tyrosine kinase inhibitor (TKI) plus immune checkpoint inhibitor (ICI)
Standard-of-care non-immune checkpoint inhibitor (ICI) such as single-agent VEGFR2 TKIDRUG

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

Non-ICI therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Kidney NeoplasmsCarcinoma, Renal Cell

Interventions

Ultrasonography, DopplerReceptor Protein-Tyrosine KinasesTyrosine Kinase Inhibitors

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

UltrasonographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisProtein-Tyrosine KinasesProtein KinasesPhosphotransferases (Alcohol Group Acceptor)PhosphotransferasesTransferasesEnzymesEnzymes and CoenzymesIntracellular Signaling Peptides and ProteinsProteinsAmino Acids, Peptides, and ProteinsReceptors, Cell SurfaceMembrane ProteinsProtein Kinase InhibitorsEnzyme InhibitorsMolecular Mechanisms of Pharmacological ActionPharmacologic ActionsChemical Actions and Uses

Results Point of Contact

Title
Dr. Alice Fan
Organization
Stanford University
afan@stanford.edu
(650) 498-6000

Study Officials

  • Alice C Fan, MD

    Stanford University

    PRINCIPAL INVESTIGATOR

  • Jeremy Dahl, PhD

    Stanford University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Medicine

Study Record Dates

First Submitted

July 29, 2020

First Posted

August 11, 2020

Study Start

December 5, 2020

Primary Completion

November 30, 2023

Study Completion

November 30, 2023

Last Updated

July 25, 2025

Results First Posted

July 25, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)