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