Use of High-Resolution Microendoscopy (HRME) in Patients With Cervical Dysplasia

Cervical Cancer Clinical Trial

Official title:

Use of High-Resolution Microendoscopy (HRME) in Patients With Cervical Dysplasia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02420665
• Other study ID #: 2014-0368
• Secondary ID: HHSN261200800001
• Status: Completed
• Phase: Early Phase 1
• Start date: September 23, 2015
• Est. completion date: May 14, 2021

Study information

• Verified date: May 2021
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this clinical research study is to compare a type of imaging called high-resolution microendoscopy (HRME) for detecting abnormal tissue in the cervix to the standard of care, which is visual inspection with acetic acid (VIA) with a colposcopy procedure. Researchers also want to learn if HRME images can show the difference between cancerous tissue and normal cervical tissue.

Description:

If you are found to be eligible to take part in this study, you will first have your scheduled VIA and colposcopy. The study doctor will tell you more about this procedure.

You will then have proflavine hemisulfate solution (contrast dye) applied to your cervix. Images will be collected with the probe from the HRME device. The HRME probe is a long thin tube with a camera at the tip. This should add about 10 minutes to the total procedure time.

The HRME images will be stored in an electronic database and used for research. The images will be deidentified and only the MD Anderson staff will have access. This data will be stored in the database indefinitely (forever).

Any abnormal areas found during the VIA and/or colposcopy will be biopsied as part of your standard of care using very small forceps (a medical tool that is like tongs). If the exam shows no abnormalities, a normal area will be biopsied.

The study doctor will talk to you about the results of the HRME imaging, colposcopy, and biopsy/ies.

There will be no change to the planned standard-of-care colposcopy and biopsy.

Researchers will also collect information from your medical record about the colposcopy, surgery, the status of the disease, and demographics (such as your age).

Follow-Up:

About 1 month after the study procedure, the study staff will contact you by phone to ask how you are doing. The call should last about 5 minutes.

Length of Study:

Your active participation in this study will be over after the biopsy.

This is an investigational study. Proflavine hemisulfate is not FDA approved or commercially available. The HRME device is not FDA approved or commercially available. Both are currently being used for research purposes only.

Up to 800 participants will be enrolled in this study. Up to 400 will take part at MD Anderson and up to 400 will take part at the Harris Health System.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: May 14, 2021
• Est. primary completion date: May 14, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

1. Women undergoing colposcopy for an abnormal Pap test, positive HPV test or history of cervical dysplasia (CIN or AIS)

2. Women of childbearing potential must have a negative pregnancy test

3. Women who are at least 21 years of age or older

4. Ability to understand and the willingness to provide informed consent and sign a written Informed Consent Document (ICD)

Exclusion Criteria:

1. Women < 21 years of age

2. Women with a known allergy to proflavine or acriflavine

3. Women who are pregnant or nursing

4. Patients unable or unwilling to provide informed consent or sign a written Informed Consent Document (ICD)

Related Conditions & MeSH terms

• Cervical Cancer
• Cervical Intraepithelial Neoplasia
• Uterine Cervical Dysplasia
• Uterine Cervical Neoplasms

Intervention

Drug:
• Proflavine
0.01% Proflavine applied topically to the cervix after colposcopy and HRME cervical images obtained.

Device:
• HRME Imaging
HRME images obtained from one visually normal cervical site, and from up to 3 visually abnormal lesions based on exam and/or colposcopic findings.

Behavioral:
• Phone Call
Study staff follow up with participant by phone one month after procedure.

Procedure:
• Colposcopy
Colposcopy performed after visual inspection of cervix.

Drug:
• Acetic Acid
3 - 5% added to cervix before visual inspection.

Locations

Country	Name	City	State
United States	Lyndon B. Johnson General Hospital	Houston	Texas
United States	University of Texas MD Anderson Cancer Center	Houston	Texas

Sponsors (3)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	National Cancer Institute (NCI), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Concordance Between the Diagnosis Using HRME Imaging and the Most Severe Histologic Diagnosis ( Concordance rate monitored using method described by Thall et al. (1995))	To evaluate the performance of HRME imaging compared with existing diagnostic techniques including colposcopy and visual inspection with acetic acid (VIA), a successful outcome is defined as concordance between the diagnosis using HRME imaging and the most severe histologic diagnosis. That is, researchers will calculate the concordance with the participant as the experimental unit rather than the biopsy, as each participant may have more than 1 biopsy. Target concordance rate is 70%. Concordance rate monitored using method described by Thall et al. (1995), and trial stopped if concordance rate is less than 70%.	1 day

External Links

•   University of Texas MD Anderson Cancer Center Website