NCT05206942

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 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).

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial recruitment is currently suspended
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
5mo left

Started Mar 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress91%
Mar 2022Sep 2026

First Submitted

Initial submission to the registry

January 12, 2022

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 25, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

March 21, 2022

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 28, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 28, 2026

Last Updated

May 6, 2026

Status Verified

May 1, 2026

Enrollment Period

4.5 years

First QC Date

January 12, 2022

Last Update Submit

May 4, 2026

Conditions

Solid Tumor

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Initial relative change in tumor burden

    16 weeks

  • Initial lesion response

    16 weeks

  • progression-free survival (PFS)

    12 months

Study Arms (1)

Ultrasound

EXPERIMENTAL

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

Diagnostic Test: Doppler ultrasoundDiagnostic Test: Long Ensemble Angular-coherence Doppler [LEAD] ultrasoundDiagnostic Test: Contrast-enhanced ultrasound (CEUS)

Interventions

Contrast-enhanced ultrasound (CEUS)DIAGNOSTIC_TEST

Contrast-enhanced ultrasound measurements will be made using Lumason IV contrast injection followed by an injection of normal saline

Ultrasound
Doppler ultrasoundDIAGNOSTIC_TEST

Power Doppler measurements will be made using a portable Siemens S2000 or S3000 ultrasound scanner

Ultrasound
Long Ensemble Angular-coherence Doppler [LEAD] ultrasoundDIAGNOSTIC_TEST

Long Ensemble Angular-coherence Doppler measurements will be made using a Verasonics Vantage 256 scanner

Ultrasound

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford

Palo Alto, California, 94305, United States

Location

MeSH Terms

Interventions

Ultrasonography, DopplerUltrasonography

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Alice C. Fan, MD

    Stanford University

    PRINCIPAL INVESTIGATOR

  • Jeremy Dahl, Ph.D

    Stanford University

    PRINCIPAL INVESTIGATOR

  • Aya Kamaya, M.D

    Stanford University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 12, 2022

First Posted

January 25, 2022

Study Start

March 21, 2022

Primary Completion (Estimated)

September 28, 2026

Study Completion (Estimated)

September 28, 2026

Last Updated

May 6, 2026

Record last verified: 2026-05

Locations

US(1)