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).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
30
Power Doppler measurements will be made using a portable Siemens S2000 or S3000 ultrasound scanner
Long Ensemble Angular-coherence Doppler measurements will be made using a Verasonics Vantage 256 scanner
Contrast-enhanced ultrasound measurements will be made using Lumason IV contrast injection followed by an injection of normal saline
Stanford
Palo Alto, California, United States
Initial objective response per RECIST v1.1
Initial objective response is defined as having either Complete Response (CR) or Partial Response (PR) per RECIST v1.1
Time frame: 16 weeks
Initial relative change in tumor burden
defined as relative change in the sum of diameters of all measurable tumors, assessed between treatment 'baseline' and first on-treatment response evaluation
Time frame: 16 weeks
Initial lesion response
defined as the relative change in tumor diameter of a single lesion between treatment 'baseline' and first on-treatment response evaluation
Time frame: 16 weeks
progression-free survival (PFS)
defined as not having experienced any PD per RECIST v1.1
Time frame: 12 months
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