Use of Fluorescence Imaging and High-Resolution Microendoscopy to Guide Hysteroscopic Tumor Resection in Patients With Endometrial Cancer
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 主要终点
- Absence of Residual Disease in Hysterectomy Specimen
研究概览
简要总结
The goal of this clinical research study is to learn if imaging (called a hysteroscopy) can be used to help guide tumor removal during a hysterectomy.
详细描述
Tissue Collection and Imaging:
If participant is found to be eligible to take part in this study, during their standard-of-care hysterectomy, a tissue sample will be collected. This sample will be used for research and routine testing. Participant will sign a separate consent form for the hysterectomy.
During the hysterectomy, photographs of the tissue will be taken. Participant's private areas will be covered (as much as possible), and a picture of their face will not be taken.
A hysteroscopy will also be performed during participant's surgery. Participant's doctor will discuss the risks of the hysteroscopy with participant and they will be asked to sign a separate consent form. A hysteroscopy allows the doctor to look inside the uterus to see the tissue that is going to be collected for research imaging. This procedure is done with a tool called a hysteroscope, a long thin tube with a camera and a light. The hysteroscope will be inserted though the vagina and up into the uterus. An image will be displayed on a computer screen that is attached to the hysteroscope. The study doctor will use the image on the screen to look at different areas of the uterus to find the location and size of the tumor(s). This image may be recorded for future reference.
After the hysteroscopy, the study doctor will inject a contrast dye (Proflavine Hemisulfate) into participant's uterus to help the doctor see the lesions. A camera will then be used to photograph images of the uterus.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •Any patient with a confirmed preoperative diagnosis of endometrial cancer
- •Histologic subtype limited to endometrioid adenocarcinoma
- •Patients with any grade of endometrial cancer (histologically confirmed)
- •Patients with no contraindications to surgery
- •Patients scheduled for hysterectomy by laparotomy, laparoscopy, or robotic surgery
- •Patient must have had a preoperative MRI within 30 days of surgery at MD Anderson Cancer Center. Outside imaging will be allowed provided that staff radiologist at MD Anderson consider the quality of the study optimal to make a definitive diagnosis regarding myometrial invasion
- •Patients must have <50% myometrial invasion on preoperative MRI
- •Patients must have disease confined to either anterior or posterior wall of the uterus
- •Ability to understand and the willingness to sign a written Informed Consent Document (ICD).
排除标准
- •Patients with invasive uterine disease (>50% invasion) by preoperative MRI
- •Patients with a diagnosis of leiomyomata affecting the endometrium
- •Patients with a prior history of endometrial ablation
- •Patients with multifocal disease within the uterus on preoperative MRI
- •Patients with polypoid tumors protruding through the endocervical canal
- •Patients with histology other than endometrioid adenocarcinoma
- •Patients who have undergone a prior D&C for diagnosis of endometrial cancer
- •Patients with exposure to metformin within 6 months of endometrial cancer diagnosis or at the time of diagnosis
- •Patients < 18 years of age
- •Patients with a known allergy to proflavine or acriflavine
- •Patients that are pregnant or nursing
研究组 & 干预措施
Hysteroscope Imaging
All patients entered in study will undergo cervical dilation after induction of general anesthesia. Once the cervix has been dilated, a hysteroscope will be introduced in the uterine cavity to evaluate for presence of tumor. Location and size of tumor documented. White-light images obtained using the High-Resolution Microendoscopy (HRME) camera introduced through the hysteroscope. Once completed; the hysteroscope will be removed and the uterine cavity will be infused with 10 mL of proflavine (an acridine dye) (0.01% Proflavine (10ml)). A resectoscope will then be introduced in the uterine cavity and fluorescent images obtained using the HRME camera. The resectoscope will then be used to remove all tumor as guided through HRME images. The entire imaging and tumor resection process is estimated to take 45 minutes or less.
干预措施: High-Resolution Microendoscopy Imaging (Procedure)
Hysteroscope Imaging
All patients entered in study will undergo cervical dilation after induction of general anesthesia. Once the cervix has been dilated, a hysteroscope will be introduced in the uterine cavity to evaluate for presence of tumor. Location and size of tumor documented. White-light images obtained using the High-Resolution Microendoscopy (HRME) camera introduced through the hysteroscope. Once completed; the hysteroscope will be removed and the uterine cavity will be infused with 10 mL of proflavine (an acridine dye) (0.01% Proflavine (10ml)). A resectoscope will then be introduced in the uterine cavity and fluorescent images obtained using the HRME camera. The resectoscope will then be used to remove all tumor as guided through HRME images. The entire imaging and tumor resection process is estimated to take 45 minutes or less.
干预措施: Proflavine (Drug)
结局指标
主要结局
Absence of Residual Disease in Hysterectomy Specimen
时间窗: 1 day
Descriptive statistics used to summarize the expression in tumor tissue and in normal tissue for each of the molecular markers assessed, as well as the difference in tumor and normal tissue within patient. Paired t-test used to compare the tumor and normal tissue with respect to the mean difference in expression of each marker, pairing tumor and normal tissue on patient. Boxplots used to illustrate the distribution of the difference in expression in tumor and normal tissue for each marker.
次要结局
未报告次要终点