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

Solid Tumor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05206942
• Other study ID #: IRB-59526
• Status: Recruiting
• Phase: N/A
• Start date: March 21, 2022
• Est. completion date: February 28, 2026

Study information

• Verified date: March 2024
• Source: Stanford University
• Contact: Christian R Hoerner
• Phone: 650-721-3206
• Email: hoerner[@]stanford.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: February 28, 2026
• Est. primary completion date: February 28, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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

Related Conditions & MeSH terms

• Neoplasms
• Solid Tumor

Intervention

Diagnostic Test:
• Doppler ultrasound
Power Doppler measurements will be made using a portable Siemens S2000 or S3000 ultrasound scanner
• Long Ensemble Angular-coherence Doppler [LEAD] ultrasound
Long Ensemble Angular-coherence Doppler measurements will be made using a Verasonics Vantage 256 scanner
• Contrast-enhanced ultrasound (CEUS)
Contrast-enhanced ultrasound measurements will be made using Lumason IV contrast injection followed by an injection of normal saline

Locations

Country	Name	City	State
United States	Stanford	Palo Alto	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	16 weeks
Secondary	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	16 weeks
Secondary	Initial lesion response	defined as the relative change in tumor diameter of a single lesion between treatment 'baseline' and first on-treatment response evaluation	16 weeks
Secondary	progression-free survival (PFS)	defined as not having experienced any PD per RECIST v1.1	12 months