Overview

High-Resolution Microendoscopy to Guide Hysteroscopic Tumor Resection

Status:
Withdrawn
Trial end date:
2015-03-01
Target enrollment:
0
Participant gender:
Female
Summary
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborator:
Ovarian Spore
Treatments:
Proflavine
Criteria
Inclusion Criteria:

1. Any patient with a confirmed preoperative diagnosis of endometrial cancer

2. Histologic subtype limited to endometrioid adenocarcinoma

3. Patients with any grade of endometrial cancer (histologically confirmed)

4. Patients with no contraindications to surgery

5. Patients scheduled for hysterectomy by laparotomy, laparoscopy, or robotic surgery

6. 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

7. Patients must have <50% myometrial invasion on preoperative MRI

8. Patients must have disease confined to either anterior or posterior wall of the uterus

9. Ability to understand and the willingness to sign a written Informed Consent Document
(ICD).

Exclusion Criteria:

1. Patients with invasive uterine disease (>50% invasion) by preoperative MRI

2. Patients with a diagnosis of leiomyomata affecting the endometrium

3. Patients with a prior history of endometrial ablation

4. Patients with multifocal disease within the uterus on preoperative MRI

5. Patients with polypoid tumors protruding through the endocervical canal

6. Patients with histology other than endometrioid adenocarcinoma

7. Patients who have undergone a prior D&C for diagnosis of endometrial cancer

8. Patients with exposure to metformin within 6 months of endometrial cancer diagnosis or
at the time of diagnosis

9. Patients < 18 years of age

10. Patients with a known allergy to proflavine or acriflavine

11. Patients that are pregnant or nursing