Clinical trial · Interventional
High-Resolution Microendoscopy to Guide Hysteroscopic Tumor Resection
Use of Fluorescence Imaging and High-Resolution Microendoscopy to Guide Hysteroscopic Tumor Resection in Patients With Endometrial Cancer
NCT02095847CI-TRIAL-00017438withdrawnPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Uterine Cancer | Malignant Uterine Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| High-Resolution Microendoscopy Imaging | Procedure | — | UNRESOLVED |
| Proflavine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Hysteroscope Imaging
- description
- 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.
- interventionNames
- Procedure: High-Resolution Microendoscopy Imaging
- Drug: Proflavine
Primary outcomes (1)
- measure
- Absence of Residual Disease in Hysterectomy Specimen
- timeFrame
- 1 day
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.