Serial Ultrasound in Metastatic Renal Cell Carcinoma (mRCC)
Study Details
Study Description
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
Condition or Disease | Intervention/Treatment | Phase |
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N/A |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: Doppler Ultrasound Patients receiving standard of care anti-angiogenesis inhibitor plus immune checkpoint inhibitor will have power doppler imaging at baseline, 3 weeks and 6 weeks. |
Diagnostic Test: Doppler Ultrasound
Power doppler measurements will be made
Device: Vantage 256 with C5-2v transducer
Vantage 256 with C5-2v transducer, used for power doppler ultrasound, manufactured by Verasonics
|
Outcome Measures
Primary Outcome Measures
- 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
- 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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18 years of age or older
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Pathology-confirmed diagnosis of metastatic RCC now
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at least one tumor lesion greater than 1 cm in diameter, amenable to ultrasound imaging
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planned to be treated with VEGFR2 tyrosine kinase inhibitor plus immune checkpoint inhibitor
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written informed consent.
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.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Stanford University School of Medicine | Stanford | California | United States | 94305 |
Sponsors and Collaborators
- Stanford University
- National Institutes of Health (NIH)
Investigators
- Principal Investigator: Alice C Fan, MD, Stanford University
- Principal Investigator: Jeremy Dahl, PhD, Stanford University
Study Documents (Full-Text)
More Information
Publications
None provided.- IRB-55742
- RENAL0042
- NCI-2021-02327
- 1R03CA25277601