Solid Tumor
Conditions
Brief 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).
Interventions
DIAGNOSTIC_TESTDoppler ultrasound
Power Doppler measurements will be made using a portable Siemens S2000 or S3000 ultrasound scanner
DIAGNOSTIC_TESTLong Ensemble Angular-coherence Doppler [LEAD] ultrasound
Long Ensemble Angular-coherence Doppler measurements will be made using a Verasonics Vantage 256 scanner
DIAGNOSTIC_TESTContrast-enhanced ultrasound (CEUS)
Contrast-enhanced ultrasound measurements will be made using Lumason IV contrast injection followed by an injection of normal saline
Sponsors
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Stanford University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Initial objective response per RECIST v1.1 | 16 weeks | Initial objective response is defined as having either Complete Response (CR) or Partial Response (PR) per RECIST v1.1 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Initial relative change in tumor burden | 16 weeks | defined as relative change in the sum of diameters of all measurable tumors, assessed between treatment 'baseline' and first on-treatment response evaluation |
| Initial lesion response | 16 weeks | defined as the relative change in tumor diameter of a single lesion between treatment 'baseline' and first on-treatment response evaluation |
| progression-free survival (PFS) | 12 months | defined as not having experienced any PD per RECIST v1.1 |
Countries
United States
Contacts
Primary ContactChristian R Hoerner
Outcome results
None listed