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

Stanford University

Status: Enrolling

Conditions: Solid Tumor

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

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05206942

IRB-59526

NCI-2022-02835 (Registry Identifier)

5R21CA259756-02 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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).

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Ultrasound

Experimental group

Description:

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

Treatment:

Diagnostic Test: Doppler ultrasound

Diagnostic Test: Contrast-enhanced ultrasound (CEUS)

Diagnostic Test: Long Ensemble Angular-coherence Doppler [LEAD] ultrasound