Serial Ultrasound of Solid Tumor Lesions to Detect Early Response to Cancer Immunotherapy

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 current standard-of-care

Secondary objectives are to evaluate if there is an optimal ultrasound imaging modality (CEUS or conventional power Doppler or LEAD ultrasound) or optimal time point to predict initial objective response and to assess the correlation of tumor perfusion parameters with change in overall tumor burden, change in diameter on a per-lesion basis, and with 12-month progression-free survival (PFS).

Study Overview

• Status: Suspended
• Conditions: Solid Tumor
• Intervention / Treatment: Diagnostic test: Contrast-enhanced ultrasound (CEUS); Diagnostic test: Doppler ultrasound; Diagnostic test: Long Ensemble Angular-coherence Doppler [LEAD] ultrasound

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Palo Alto, California, United States, 94305
      • Stanford

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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 Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Ultrasound; Patients receiving standard of care immune checkpoint inhibitor are followed with the ultrasound studies at treatment baseline, 3 weeks and 6 weeks.

Diagnostic test: Contrast-enhanced ultrasound (CEUS); Contrast-enhanced ultrasound measurements will be made using Lumason IV contrast injection followed by an injection of normal saline; Diagnostic test: Doppler ultrasound; Power Doppler measurements will be made using a portable Siemens S2000 or S3000 ultrasound scanner; Diagnostic test: Long Ensemble Angular-coherence Doppler [LEAD] ultrasound; Long Ensemble Angular-coherence Doppler measurements will be made using a Verasonics Vantage 256 scanner

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Initial objective response per RECIST v1.1	Initial objective response is defined as having either Complete Response (CR) or Partial Response (PR) per RECIST v1.1	16 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Initial relative change in tumor burden	defined as relative change in the sum of diameters of all measurable tumors, assessed between treatment 'baseline' and first on-treatment response evaluation	16 weeks
Initial lesion response	defined as the relative change in tumor diameter of a single lesion between treatment 'baseline' and first on-treatment response evaluation	16 weeks
progression-free survival (PFS)	defined as not having experienced any PD per RECIST v1.1	12 months

Collaborators and Investigators

• Sponsor: Stanford University
• Collaborators: National Cancer Institute (NCI); National Institutes of Health (NIH)
• Investigators: Principal Investigator: Alice C. Fan, MD, Stanford University; Principal Investigator: Jeremy Dahl, Ph.D, Stanford University; Principal Investigator: Aya Kamaya, M.D, Stanford University

Study record dates

Study Major Dates

• Study Start (Actual): March 21, 2022
• Primary Completion (Estimated): September 28, 2026
• Study Completion (Estimated): September 28, 2026

Study Registration Dates

• First Submitted: January 12, 2022
• First Submitted That Met QC Criteria: January 12, 2022
• First Posted (Actual): January 25, 2022

Study Record Updates

• Last Update Posted (Actual): May 6, 2026
• Last Update Submitted That Met QC Criteria: May 4, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Imaging; Ultrasonography; Ultrasonography, Doppler
• Other Study ID Numbers: IRB-59526; NCI-2022-02835 (Registry Identifier: National Cancer Institute Clinical Trials Reporting Program); 5R21CA259756-02 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No