This clinical trial tests whether ultrasound scans can detect early response to treatment for renal cell carcinoma (RCC) that has spread to other places in the body (advanced) with immunotherapy earlier than current standard-of-care computed tomography (CT), positron emission tomography/CT (PET/CT), or magnetic resonance imaging (MRI). Ultrasound is a procedure in which high-energy sound waves are bounced off internal tissues or organs and make echoes. The echo patterns are shown on the screen of an ultrasound machine, forming a picture of body tissues called a sonogram. This study may help researchers determine if different types of ultrasound (Doppler, Long Ensemble Angular-coherence Doppler [LEAD], and contrast-enhanced ultrasound [CEUS]) can detect changes in the blood flow in the tumor(s) and thereby serve to know earlier than current standard-of-care scans whether the treatment is working.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT05206942.
Locations matching your search criteria
United States
California
Palo Alto
Stanford Cancer Institute Palo AltoStatus: Temporarily closed to accrual
Contact: Alice Fan
Phone: 650-498-6000
PRIMARY OBJECTIVE:
I. To develop a predictive model to assess whether changes in quantitative tumor perfusion parameters 3 weeks after start of treatment of renal cell carcinoma (RCC) patients with immune checkpoint inhibitor (ICI) therapy, for example with ipilimumab plus nivolumab, as measured by LEAD ultrasound and CEUS, can predict initial objective response to therapy at 12 weeks after start of treatment defined by current standard-of-care Response Evaluation Criteria In Solid Tumors (RECIST v1.1).
SECONDARY OBJECTIVE:
I. To evaluate if there is an optimal ultrasound imaging modality (conventional power Doppler or LEAD ultrasound or CEUS) or optimal time point to predict initial objective response.
EXPLORATORY OBJECTIVE:
I. To assess the correlation of tumor perfusion parameters with change in overall tumor burden 12 weeks after start of treatment, with change in diameter on a per-lesion basis, and with 12-month progression-free survival (PFS).
OUTLINE:
Patients undergo 3 ultrasound sessions: Conventional power Doppler, LEAD, and CEUS at baseline, 3, and 6 weeks after start of standard of care ICI therapy.
After completion of study treatment, patients are followed up periodically for up to 3 years.
Trial PhaseNo phase specified
Trial Typediagnostic
Lead OrganizationStanford Cancer Institute Palo Alto
Principal InvestigatorAlice Fan
