High-Resolution Microendoscopy to Guide Hysteroscopic Tumor Resection

NCT02095847 | Withdrawn Phase 2

• 1 other identifier: 2012-1080
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Uterine Cancer

Keywords

Uterine Cancer; Endometrial cancer; Hysterectomy; Hysteroscopy; High-resolution microendoscopy; HRME; Hysteroscopic-guided resection; Proflavine

Outcome Measures

Primary Outcomes (1)

• Absence of Residual Disease in Hysterectomy Specimen

  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.

  1 day

Study Arms (1)

Hysteroscope Imaging

EXPERIMENTAL

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.

Procedure: High-Resolution Microendoscopy Imaging; Drug: Proflavine

Interventions

High-Resolution Microendoscopy Imaging PROCEDURE

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 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.

Also known as: HRME

Hysteroscope Imaging

Proflavine DRUG

After hysteroscopy with HRME camera, uterine cavity infused with 10 mL of Proflavine.

Hysteroscope Imaging

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Ovarian Spore: collaborator

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Conditions

Uterine Neoplasms; Endometrial Neoplasms

Interventions

Proflavine

Condition Hierarchy (Ancestors)

Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Aminoacridines; Acridines; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Pedro Ramirez, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2014
• First Posted: March 26, 2014
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: April 8, 2015

Record last verified: 2015-04