Serial Ultrasound of Solid Tumor Lesions to Detect Early Response to Cancer Immunotherapy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Initial objective response per RECIST v1.1
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Ultrasound
Patients receiving standard of care immune checkpoint inhibitor are followed with the ultrasound studies at treatment baseline, 3 weeks and 6 weeks.
干预措施: Doppler ultrasound (Diagnostic Test)
Ultrasound
Patients receiving standard of care immune checkpoint inhibitor are followed with the ultrasound studies at treatment baseline, 3 weeks and 6 weeks.
干预措施: Long Ensemble Angular-coherence Doppler [LEAD] ultrasound (Diagnostic Test)
Ultrasound
Patients receiving standard of care immune checkpoint inhibitor are followed with the ultrasound studies at treatment baseline, 3 weeks and 6 weeks.
干预措施: Contrast-enhanced ultrasound (CEUS) (Diagnostic Test)
结局指标
主要结局
Initial objective response per RECIST v1.1
时间窗: 16 weeks
Initial objective response is defined as having either Complete Response (CR) or Partial Response (PR) per RECIST v1.1
次要结局
- Initial relative change in tumor burden(16 weeks)
- Initial lesion response(16 weeks)
- progression-free survival (PFS)(12 months)