Pilot Study of Ultrasound and Photoacoustic Imaging for Assessing Treatment Response of Cervical Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Number of participants who complete the imaging protocol
研究概览
简要总结
The investigators have developed co-registered transvaginal photoacoustic and ultrasound (US) imaging techniques that allow them to visualize ovarian tumor structure and functional changes simultaneously, which may potentially reveal early tumor angiogenesis development or residual tumors after systemic treatment that is not available by US alone. The ability to detect early angiogenesis changes, as well as tumor morphology changes using a non-invasive imaging modality will greatly enhance the care for patients. The investigators plan to explore these techniques in monitoring cervical cancer treatment response and conduct pilot feasibility studies.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of cervical cancer of any stage that will be treated with radiation therapy and concurrent chemotherapy.
- •At least 18 years of age.
- •Not pregnant and/or breastfeeding.
- •Able to understand and willing to sign an IRB-approved written informed consent document.
排除标准
- 未提供
研究组 & 干预措施
Transvaginal probe (Photoacoustic + ultrasound imaging)
- A transvaginal imaging probe using ultrasound and photoacoustic imaging will be inserted into the vagina and will use different frequencies of lights to create images
- This will occur before the first standard of care treatment, mid-treatment, end of treatment, and approximately 3 months after the end of treatment for a total of 4 imaging time points
干预措施: Transvaginal probe using photoacoustic and ultrasound imaging (Device)
结局指标
主要结局
Number of participants who complete the imaging protocol
时间窗: Approximately 18 weeks
次要结局
- Reduction rate of tumor angiogenesis(3 months after completion of standard of care treatment (approximately 18 weeks))
- Charge pattern of blood oxygen saturation(3 months after completion of standard of care treatment (approximately 18 weeks))