High-Resolution Microendoscopy to Guide Hysteroscopic Tumor Resection
Uterine Cancer
About this trial
This is an interventional treatment trial for Uterine Cancer focused on measuring Uterine Cancer, Endometrial cancer, Hysterectomy, Hysteroscopy, High-resolution microendoscopy, HRME, Hysteroscopic-guided resection, Proflavine
Eligibility Criteria
Inclusion Criteria:
- 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).
Exclusion Criteria:
- 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
Sites / Locations
Arms of the Study
Arm 1
Experimental
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.