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


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Trial ID: NCT05206942


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).

Official Title

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

Stanford Investigator(s)

Alice C. Fan
Alice C. Fan

Assistant Professor of Medicine (Oncology) and, by courtesy, of Urology

Luyao Shen, MD

Clinical Associate Professor, Radiology

Sunil Arani Reddy
Sunil Arani Reddy

Clinical Associate Professor, Medicine - Oncology


Inclusion Criteria:

   - 18 years of age or older

   - pathology-confirmed diagnosis of cancer

   - 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

   - 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


diagnostic test: Doppler ultrasound

diagnostic test: Long Ensemble Angular-coherence Doppler [LEAD] ultrasound

diagnostic test: Contrast-enhanced ultrasound (CEUS)


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Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Christian Remy Hoerner

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