Serial Ultrasound in Metastatic Renal Cell Carcinoma (mRCC)

Renal Cell Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04508725
• Other study ID #: IRB-55742
• Secondary ID: RENAL0042NCI-202
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 5, 2020
• Est. completion date: December 2024

Study information

• Verified date: February 2024
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 22
• Est. completion date: December 2024
• Est. primary completion date: November 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 years of age or older

• Pathology-confirmed diagnosis of metastatic 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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Renal Cell
• Kidney Cancer
• Kidney Neoplasms
• Metastatic Renal Cell Carcinoma
• Renal Cell Carcinoma

Intervention

Diagnostic Test:
• Doppler Ultrasound
Power doppler measurements will be made

Device:
• SIEMENS S3000 and Verasonics Vantage 256
Vantage 256 used for power doppler ultrasound, manufactured by Verasonics

Drug:
• Vascular Endothelial Growth Factor Receptor 2 tyrosine kinase inhibitor plus immune checkpoint inhibitor
Participants will receive less than 4 weeks of TKI treatment during the first 12 weeks. Plus immune checkpoint inhibitor (arm 1) or non-immune checkpoint inhibitor (arm 2)

Locations

Country	Name	City	State
United States	Stanford University School of Medicine	Stanford	California

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measure Initial Objective response	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.	12 weeks
Secondary	Relative change in tumor burden compared to baseline	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	12 weeks
Secondary	Lesion response compared to baseline	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.	12 weeks
Secondary	Progression free survival (PFS)	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.	12 months