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Serial Ultrasound of Solid Tumor Lesions to Detect Early Response to Cancer Immunotherapy
Recruiting
I'm InterestedTrial ID: NCT05206942
Purpose
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
Assistant Professor of Medicine (Oncology) and, by courtesy, of Urology
Luyao Shen, MD
Clinical Associate Professor, Radiology
Sunil Arani Reddy
Clinical Associate Professor, Medicine - Oncology
Eligibility
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
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
Intervention(s):
diagnostic test: Doppler ultrasound
diagnostic test: Long Ensemble Angular-coherence Doppler [LEAD] ultrasound
diagnostic test: Contrast-enhanced ultrasound (CEUS)
Recruiting
I'm InterestedContact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Christian Remy Hoerner
650-721-3206