Status:
RECRUITING
Serial Ultrasound of Solid Tumor Lesions to Detect Early Response to Cancer Immunotherapy
Lead Sponsor:
Stanford University
Collaborating Sponsors:
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Conditions:
Solid Tumor
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Primary objective is to assess whether changes in quantitative tumor perfusion parameters after 3 weeks of treatment, as measured by CEUS, can predict initial objective response to therapy, defined by...
Eligibility Criteria
Inclusion
- 18 years of age or older
- at least one solid tumor lesion greater than 1 cm in diameter (primary tumor and/or at metastatic site), amenable to ultrasound imaging
- planned to be treated with ICI therapy (single agent or in combination with any other drug)
- written informed consent.
- prior use of any ICI is not necessarily excluded, and patients may be included with the approval of the Protocol Director
- Subjects may participate in the study more than once at the discretion of the Protocol Director, for example, if they receive different lines of treatment that all qualify for the study.
Exclusion
- known hypersensitivity to sulfur hexafluoride lipid microsphere or its components, such as polyethylene glycol (PEG)
- 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
- Examples: any mental condition that compromises the ability to follow a consent discussion, or to make informed decisions (except if represented by a Legally Authorized Representative \[LAR\]), or to have ultrasound exams.
Key Trial Info
Start Date :
March 21 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 28 2026
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT05206942
Start Date
March 21 2022
End Date
February 28 2026
Last Update
August 1 2025
Active Locations (1)
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1
Stanford
Palo Alto, California, United States, 94305