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

Completed · Early Phase 1

Conditions studied: Cervical Cancer

In brief

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.

Key facts

Study ID

NCT02420665

Run by

M.D. Anderson Cancer Center

People needed

50

Starts

2015-09-23

Expected to finish

2021-05-14

Last updated by the study team

2021-05-28

Who can join

Age: 21 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Women undergoing colposcopy for an abnormal Pap test, positive HPV test or history of cervical dysplasia (CIN or AIS)
• Women of childbearing potential must have a negative pregnancy test
• Women who are at least 21 years of age or older
• Ability to understand and the willingness to provide informed consent and sign a written Informed Consent Document (ICD)

You may not qualify if…

• Women < 21 years of age
• Women with a known allergy to proflavine or acriflavine
• Women who are pregnant or nursing
• Patients unable or unwilling to provide informed consent or sign a written Informed Consent Document (ICD)

Where it is running

• Lyndon B. Johnson General Hospital — Houston, Texas, United States
• University of Texas MD Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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