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

Not Applicable

Recruiting

• Conditions: Solid Tumor
• Interventions: Diagnostic Test: Doppler ultrasound; Diagnostic Test: Long Ensemble Angular-coherence Doppler [LEAD] ultrasound; Diagnostic Test: Contrast-enhanced ultrasound (CEUS)

• Registration Number: NCT05206942
• Lead Sponsor: Stanford University

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).

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2022-01-12
• Study First Submitted QC: 2022-01-12
• Study First Posted: 2022-01-25
• Study Start: 2022-03-21
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-04
• Last Update Posted: 2024-03-06
• Primary Completion: 2025-02-28
• Study Completion: 2026-02-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ultrasound	Doppler ultrasound	Patients receiving standard of care immune checkpoint inhibitor are followed with the ultrasound studies at treatment baseline, 3 weeks and 6 weeks.
Ultrasound	Long Ensemble Angular-coherence Doppler [LEAD] ultrasound	Patients receiving standard of care immune checkpoint inhibitor are followed with the ultrasound studies at treatment baseline, 3 weeks and 6 weeks.
Ultrasound	Contrast-enhanced ultrasound (CEUS)	Patients receiving standard of care immune checkpoint inhibitor are followed with the ultrasound studies at treatment baseline, 3 weeks and 6 weeks.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Stanford; 🇺🇸 Palo Alto, California, United States