A Pilot Study of Photoacoustic Endoscopy in Endometrial Cancer
试验速览
- 阶段
- 早期 1 期
- 状态
- 撤回
- 主要终点
- Feasibility of using the device to image endometrial cancer
研究概览
简要总结
The purpose of this research study is to evaluate whether a new technology called intrauterine photoacoustic endoscopy (PAE) can be used to evaluate the inner lining of the uterus.
详细描述
The investigators will evaluate whether this technology can be used and also try to obtain photoacoustic images and functional data (oxygen contents, blood vessel characteristics, etc) of the uterine lining to assess its appearance in women with and without cancer of the endometrium. Currently, it is difficult for physicians to know whether or not tumors of the endometrium have invaded and spread to other organs without performing an extended surgery called a staging operation (removal of the lymph nodes or glands that drain the uterus to assess under the microscope whether or not the cancer has spread). Our long term goal is to use this new photoacoustic (PA) technology to improve detection of occult metastatic disease. Occult disease is defined as tumor which cannot be seen without the use of imaging techniques. and possibly avoid the need of extended operations. All of this could result in better care for patients with endometrial cancer and other gynecologic problems.
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
- •Women diagnosed with benign gynecologic pathology (N=10) or biopsy proven endometrial cancer (N=10) who will undergo hysterectomy.
- •Participants must be ≥ 18 years of age.
- •Subjects of reproductive potential must have a negative pregnancy test prior to study photoacoustic endoscopy procedure and hysterectomy.
- •Subjects must be able understand and willing to sign a written informed consent form.
排除标准
- •Subjects with contraindications for general anesthesia or hysterectomy.
- •Subjects with evidence of active pelvic inflammatory disease or purulent cervicitis.
- •Subjects with prior endometrial ablation procedures.
- •Gross tumoral involvement of the cervix or lower genital tract precluding cervical dilatation and endometrial sounding.
结局指标
主要结局
Feasibility of using the device to image endometrial cancer
时间窗: 12 months or less
Feasibility of using this novel device to image endometrial cancer is our primary objective. The frequency of success in obtaining images, overall and per group, will be presented and binomial success rates with 95% confidence interval estimates will be calculated. Besides the overall success rates, graphical and tabular summaries of the feasibility across patient demographic and clinical characteristics will be created.
次要结局
未报告次要终点