N/A
Completed N=19
Serial Ultrasound in Metastatic Renal Cell Carcinoma (mRCC)
Source: ClinicalTrials.gov NCT04508725 ↗Enrolled (actual)
19
Serious AEs
0.0%
Results posted
Jul 2025
Primary outcomePrimary: Initial Objective Response- First Participation — 5; 1; 7; 4 Participants
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Initial Objective Response- First Participation |
5; 1; 7; 4 | — |
| PRIMARY Initial Objective Response- Second Participation |
0; 1 | — |
| SECONDARY Initial Relative Change in Tumor Burden Compared to Baseline - First Participation |
-16.0; 43.7 | — |
| SECONDARY Initial Relative Change in Tumor Burden Compared to Baseline - Second Participation |
-20.7 | — |
| SECONDARY Initial Per-Lesion Response Compared To Baseline - First Participation |
-28.0; -4.6 | — |
| SECONDARY Initial Per-Lesion Response Compared To Baseline - Second Participation |
-6.3 | — |
| SECONDARY 12-month Progression Free Survival (PFS)- First Participation |
7; 3; 4; 2 | — |
| SECONDARY 12-month Progression Free Survival (PFS)- Second Participation |
0; 1 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT04508725). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.