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

NCT05206942 · Status: SUSPENDED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-05-06

No results posted yet for this study

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).

Conditions

Interventions

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

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

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH

  • National Cancer Institute (NCI)

    collaborator NIH

  • Stanford University

    lead OTHER

Principal Investigators

  • Alice C. Fan, MD · Stanford University

  • Jeremy Dahl, Ph.D · Stanford University

  • Aya Kamaya, M.D · Stanford University

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-21
Primary Completion
2026-09-28
Completion
2026-09-28
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05206942 on ClinicalTrials.gov