Pilot Study to Evaluate if Contrast Enhanced Ultrasound (CEUS) Can Predict Treatment Response in Triple Negative Breast Cancer (TNBC) Patients Receiving Combined Chemotherapy and Immune Checkpoint Inhibitors (ICI).
试验速览
- 阶段
- 早期 1 期
- 状态
- 撤回
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Volume of mass on as visualized on contrast (Lumason) enhanced ultrasound at C3
研究概览
简要总结
To find out if contrast enhanced ultrasound (CEUS) can be used to determine if patients receiving combined ICI therapy for triple negative breast cancer (TNBC) are responding to treatment earlier than standard of care MR or CT.
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
- •Willingness and ability to sign and date the study-specific informed consent form.
- •Stated willingness to comply with all study procedures and attend all study visits to the best of his or her ability for the duration of the study.
- •Age greater than 18yo.
- •Stage I-III TNBC or stage IV TNBC with intact breast primary.
- •Planned combined ICI therapy as per SoC by treating oncologist.
排除标准
- •Other clinical trials are not excluded but participation must be cleared with the other clinical trial PIs.
- •Patients not suitable to undergo contrast enhanced ultrasound (i.e., pregnant women, known allergy to eggs, or a past allergic reaction to sonographic contrast or its components, such as polyethylene glycol (PEG))
研究组 & 干预措施
Contrast Enhanced Ultrasound (with Lumason)
干预措施: Lumason (Drug)
结局指标
主要结局
Volume of mass on as visualized on contrast (Lumason) enhanced ultrasound at C3
时间窗: No later than week 9
Volume of mass on as visualized on contrast (Lumason) enhanced ultrasound at C4
时间窗: No later than week 13
Contrast (Lumason) enhanced ultrasound metric-area under the curve-at Baseline
时间窗: Day 0 (Baseline)
Contrast (Lumason) enhanced ultrasound metric-area under the curve-at C4
时间窗: No later than week 13
Number of subjects who respond to treatment as reported on routine imaging.
时间窗: No later than week 17
Contrast (Lumason) enhanced ultrasound metric-area under the curve-at C2
时间窗: No later than week 5
Contrast (Lumason) enhanced ultrasound metric-area under the curve-at C3
时间窗: No later than week 9
Volume of mass on as visualized on contrast (Lumason) enhanced ultrasound at Baseline
时间窗: Day 0 (Baseline)
Volume of mass on as visualized on contrast (Lumason) enhanced ultrasound at C2
时间窗: No later than week 5
次要结局
- Change in area under the curve (CEUS metric) between Baseline & C2(No later than year 5)
- Change in area under the curve (CEUS metric) between Baseline & C3(No later than year 5)
- Change in area under the curve (CEUS metric) between Baseline & C4(No later than year 5)
- Change in area under the curve (CEUS metric) between C2 & C3(No later than year 5)
- Number of subjects having pathologic complete response(No later than year 5)
- Change in area under the curve (CEUS metric) between C2 & C4(No later than year 5)
- Change in area under the curve (CEUS metric) between C3 & C4(No later than year 5)
- Overall survival (time to subject death)(No later than year 5)
研究者
Stephanie Patton
Compliance Specialist-RQA
Milton S. Hershey Medical Center