Serial Ultrasound in Metastatic Renal Cell Carcinoma (mRCC)

Sponsor
Stanford University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04508725
Collaborator
National Institutes of Health (NIH) (NIH)
20
1
1
59.9
0.3

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
  • Diagnostic Test: Doppler Ultrasound
  • Device: Vantage 256 with C5-2v transducer
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Early Therapeutic Monitoring of Response to Therapy With Serial Ultrasound in Metastatic Renal Cell Carcinoma (mRCC)
Actual Study Start Date :
Dec 5, 2020
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Dec 1, 2025

Arms and Interventions

Arm Intervention/Treatment
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

  1. 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

  1. 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

  2. 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.

  3. 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

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • 18 years of age or older

  • Pathology-confirmed diagnosis of metastatic RCC now

  • at least one tumor lesion greater than 1 cm in diameter, amenable to ultrasound imaging

  • planned to be treated with VEGFR2 tyrosine kinase inhibitor plus immune checkpoint inhibitor

  • 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.
Responsible Party:
Stanford University
ClinicalTrials.gov Identifier:
NCT04508725
Other Study ID Numbers:
  • IRB-55742
  • RENAL0042
  • NCI-2021-02327
  • 1R03CA25277601
First Posted:
Aug 11, 2020
Last Update Posted:
Apr 13, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 13, 2022