Clinical trial NCT05206942: Serial Ultrasound of Solid Tumor Lesions to Detect Early Response to Cancer Immunotherapy
Official title: Serial Ultrasound of Solid Tumor Lesions to Detect Early Response to Cancer Immunotherapy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Solid Tumor
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Cancer Institute (NCI)
First posted: 2022-01-25
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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).


Eligibility criteria: 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

  * 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.

Primary outcomes:
measure: Initial objective response per RECIST v1.1
timeFrame: 16 weeks
Secondary outcomes:
measure: Initial relative change in tumor burden
timeFrame: 16 weeks
measure: Initial lesion response
timeFrame: 16 weeks
measure: progression-free survival (PFS)
timeFrame: 12 months
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford
state: California
Study officials:
affiliation: Stanford University
name: Alice C. Fan, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Stanford University
name: Jeremy Dahl, Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Stanford University
name: Aya Kamaya, M.D
role: PRINCIPAL_INVESTIGATOR
References: