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

NCT ID: NCT05206942

Last Updated: 2025-08-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-21

Study Completion Date

2026-02-28

Brief Summary

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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).

Detailed Description

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Conditions

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Solid Tumor

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Ultrasound

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

Group Type EXPERIMENTAL

Doppler ultrasound

Intervention Type DIAGNOSTIC_TEST

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

Long Ensemble Angular-coherence Doppler [LEAD] ultrasound

Intervention Type DIAGNOSTIC_TEST

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

Contrast-enhanced ultrasound (CEUS)

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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Doppler ultrasound

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

Intervention Type DIAGNOSTIC_TEST

Long Ensemble Angular-coherence Doppler [LEAD] ultrasound

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

Intervention Type 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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Stanford University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alice C. Fan, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Jeremy Dahl, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Aya Kamaya, M.D

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

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Stanford

Palo Alto, California, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Christian R Hoerner

Role: CONTACT

650-721-3206

Facility Contacts

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Christian Hoerner

Role: primary

(650) 721-3206

Other Identifiers

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NCI-2022-02835

Identifier Type: REGISTRY

Identifier Source: secondary_id

5R21CA259756-02

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB-59526

Identifier Type: -

Identifier Source: org_study_id

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