Kidney CancerNCT04508725

Serial Ultrasound in Metastatic Renal Cell Carcinoma (mRCC)

A study testing Doppler Ultrasound, SIEMENS S3000 and Verasonics Vantage 256 and Standard-of-care Vascular Endothelial Growth Factor Receptor 2 (VEGFR2) tyrosine kinase inhibitor (TKI) plus immune checkpoint inhibitor (ICI) in people with Kidney Cancer and Renal Cell Carcinoma, run by Stanford University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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 Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Kidney Cancer, Renal Cell Carcinoma, Metastatic Renal Cell Carcinoma
What is being tested?: Doppler Ultrasound, SIEMENS S3000 and Verasonics Vantage 256 and Standard-of-care Vascular Endothelial Growth Factor Receptor 2 (VEGFR2) tyrosine kinase inhibitor (TKI) plus immune checkpoint inhibitor (ICI)
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 22 participants
Where: 1 siteUnited States
Study dates: 5 Dec 2020to 30 Nov 2023
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

-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

Trial locations and contacts

1 site in 1 country.

United States1 site

Stanford University School of Medicine
Stanford, California, 94305

Other trials in United States

About this study

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

Conditions: Kidney Cancer, Renal Cell Carcinoma, Metastatic Renal Cell Carcinoma
Being tested: Doppler Ultrasound, SIEMENS S3000 and Verasonics Vantage 256, Standard-of-care Vascular Endothelial Growth Factor Receptor 2 (VEGFR2) tyrosine kinase inhibitor (TKI) plus immune checkpoint inhibitor (ICI), Standard-of-care non-immune checkpoint inhibitor (ICI) such as single-agent VEGFR2 TKI
Medical subject headings: Kidney Neoplasms, Carcinoma, Renal Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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
Also called VEGFR2, TKI, ICI
Standard-of-care Vascular Endothelial Growth Factor Receptor 2 (VEGFR2) 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

Study groups in NCT04508725
Study group	Role	What they receive
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) Receives: Diagnostic Test: Doppler Ultrasound; Device: SIEMENS S3000 and Verasonics Vantage 256; Drug: 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 Receives: Diagnostic Test: Doppler Ultrasound; Device: SIEMENS S3000 and Verasonics Vantage 256; Drug: Standard-of-care non-immune checkpoint inhibitor (ICI) such as single-agent VEGFR2 TKI

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 12 weeks

Secondary outcomes (6)

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
Measured: 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
Measured: 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.
Measured: 12 weeks
Initial Per-Lesion Response Compared To Baseline - Second 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.
Measured: 12 weeks
12-month Progression Free Survival (PFS)- First Participation
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).
Measured: 12 months
12-month Progression Free Survival (PFS)- Second Participation
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.
Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

5 Dec 202030 Nov 2023

First posted11 Aug 2020
Study start5 Dec 2020
Primary completion30 Nov 2023
Study completion30 Nov 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Kidney CancerStudies of the same condition, open and under way.
More trials run by Stanford UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Diagnosis
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 22 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04508725
Sponsor's protocol ID: IRB-55742
Other IDs: RENAL0042, NCI-2021-02327, 1R03CA25277601
Status last verified: Jul 2025
First submitted: 29 Jul 2020
Last updated: 25 Jul 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)
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RecruitingPhase 2/3
Testing the Role of DNA Released From Tumor Cells Into the Blood in Guiding the Use of Immunotherapy After Surgical Removal of the Bladder, Kidney, Ureter, and Urethra for Urothelial Cancer Treatment, MODERN Study
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Not yet recruitingPhase 1
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All Kidney Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Early Therapeutic Monitoring of Response to Therapy With Serial Ultrasound in Metastatic Renal Cell Carcinoma (mRCC)
ClinicalTrials.gov ID: NCT04508725
Acronym / sponsor ID: IRB-55742
Conditions: Kidney Cancer, Renal Cell Carcinoma, Metastatic Renal Cell Carcinoma
Study type: Interventional
Recruitment status: Completed
Enrolment: 22 participants (actual)
Lead sponsor: Stanford UniversityUniversity, hospital or other
Collaborators: National Institutes of Health (NIH)
Study start: 5 Dec 2020 (actual)
Primary completion: 30 Nov 2023 (actual)
Study completion: 30 Nov 2023 (actual)
First posted: 11 Aug 2020 (actual)
Results: Posted 25 Jul 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Diagnosis
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Tyrosine kinase inhibitor (TKI) plus immune checkpoint inhibitor (ICI)	Active comparator	Diagnostic Test: Doppler Ultrasound, Device: SIEMENS S3000 and Verasonics Vantage 256, Drug: Standard-of-care Vascular Endothelial Growth Factor Receptor 2 (VEGFR2) tyrosine kinase inhibitor (TKI) plus immune checkpoint inhibitor (ICI)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	Active comparator	Diagnostic Test: Doppler Ultrasound, Device: SIEMENS S3000 and Verasonics Vantage 256, Drug: Standard-of-care non-immune checkpoint inhibitor (ICI) such as single-agent VEGFR2 TKIPatients are planned to be treated with non-ICI therapy

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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.
Arm 1: planned to be treated with combination of VEGFR2 tyrosine kinase inhibitor (TKI) plus immune checkpoint inhibitor (ICI)

Key exclusion criteria (1 listed)

-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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Doppler UltrasoundPower Doppler measurements will be made	Diagnostic test	Non-ICI therapy, Tyrosine kinase inhibitor (TKI) plus immune checkpoint inhibitor (ICI)
SIEMENS S3000 and Verasonics Vantage 256Vantage 256 used for power Doppler ultrasound, manufactured by Verasonics	Device	Non-ICI therapy, Tyrosine 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)Also: VEGFR2, TKI, ICIStandard-of-care Vascular Endothelial Growth Factor Receptor 2 (VEGFR2) tyrosine kinase inhibitor (TKI) plus immune checkpoint inhibitor (ICI).	Drug	Tyrosine kinase inhibitor (TKI) plus immune checkpoint inhibitor (ICI)
Standard-of-care non-immune checkpoint inhibitor (ICI) such as single-agent VEGFR2 TKIStandard-of-care non-immune checkpoint inhibitor (ICI) such as single-agent VEGFR2 TKI	Drug	Non-ICI therapy

Primary outcome

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.
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.

6 secondary outcomes

Initial Relative Change in Tumor Burden Compared to Baseline - First Participation
Time frame: 8-16 weeks after the start of treatment
Initial Relative Change in Tumor Burden Compared to Baseline - Second Participation
Time frame: 8-16 weeks after the start of treatment
Initial Per-Lesion Response Compared To Baseline - First Participation
Time frame: 12 weeks
Initial Per-Lesion Response Compared To Baseline - Second Participation
Time frame: 12 weeks
12-month Progression Free Survival (PFS)- First Participation
Time frame: 12 months
12-month Progression Free Survival (PFS)- Second Participation
Time frame: 12 months

Results and safety

Results posted to the registry on 25 Jul 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
ARM 1: Tyrosine Kinase Inhibitor (TKI) Plus Immune Checkpoint Inhibitor (ICI)	12	10
ARM 2: Non-ICI Therapy	5	5
ARM 3: Enrolled Consecutively in Both Arms	2	2

Primary outcome: Initial Objective Response- First Participation

Time frame: 12 weeks. Count of participants. Unit: Participants

Measure	ARM 1: Tyrosine Kinase Inhibitor (TKI) Plus Immune Checkpoint Inhibitor (ICI) n = 12	ARM 2: Non-ICI Therapy n = 5
Yes (CR or PR)	5	1
No (SD or PD)	7	4

Population analysed: Two of fourteen participants in Arm 1 were not evaluable because they were removed from the study during active participation without undergoing any response evaluation.

Primary outcome: Initial Objective Response- Second Participation

Time frame: 12 weeks. Count of participants. Unit: Participants

Measure	ARM 3: Enrolled Consecutively in Both Arms n = 1
Yes (CR or PR)	0
No (SD or PD)	1

Population analysed: This measure reflects outcome data from the second participation of two individuals enrolled in both Arm 1 and Arm 2. For their second participation, these individuals are grouped under Arm 3. Each participant is counted once in this outcome based on the second treatment period. For one of the two participants the outcome measure was not defined for their second treatment period.

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: First study ultrasound exam through 12 weeks after starting treatment.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
ARM 1: Tyrosine Kinase Inhibitor (TKI) Plus Immune Checkpoint Inhibitor (ICI)	0 of 12 (0%)	2 of 12 (16.7%)	1 of 12
ARM 2: Non-ICI Therapy	0 of 5 (0%)	0 of 5 (0%)	0 of 5
ARM 3: Enrolled Consecutively in Both Arms	0 of 2 (0%)	0 of 2 (0%)	0 of 2

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Alice C Fan, MD principal investigator

Stanford University

Jeremy Dahl, PhD principal investigator

Stanford University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Initial Objective Response- First Participation (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04508725.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2025.