Low-Cost Imaging for Cervical Cancer Prevention in the Texas Lower Rio Grande Valley
Low-Cost Imaging for Cervical Cancer Prevention in the Texas Lower Rio Grande Valley
The purpose of this study is to evaluate a different type of medical equipment called
 "High-Resolution Microendoscope" (HRME) for the diagnosis of cervical pre-cancerous lesions
 and cervical cancer. The investigators want to compare patients' clinical findings using the
 current equipment used in clinic with the clinical findings using new equipment we are
 testing on this research project. If the new equipment is proven to give comparable findings
 with current equipment being used, doctors might be able to offer a diagnosis and treat
 cervical lesions in one visit. It might not be necessary to wait for cervical biopsies to
 come back before women would receive the indicated treatment. Study subjects are being asked
 to participate because they have been diagnosed with an abnormal Papanicolaou (Pap) PAP
 smear, positive human papillomavirus (HPV) test or history of cervical dysplasia and need to
 have a colposcopic examination to determine the reason for abnormal results and receive
 treatment.
Investigators will start the participants' examination with colposcopic evaluation using
 current equipment as determined by standard of care. But, if cervical biopsies are indicated,
 before performing biopsies, for research purposes only - investigators will:

 -  Apply a substance called Proflavine 0.01% to participants' cervix

 -  Investigators will re-evaluate participants' cervix with the new equipment being
 tested:The High- Resolution Microendoscope

 -  After completing this re-evaluation, investigators will continue with the standard of
 care protocol and will perform participants' cervical biopsies if indicated.

 The entire re-evaluation with the new equipment should add less than 10 minutes to the
 standard examination.

 When a woman is found to have an abnormal PAP smear, depending on the findings and clinical
 history, most women will need to be further evaluated with a colposcope in order to
 understand the reason for the abnormal PAP and determine the best treatment. This is called
 colposcopic examination and it is the standard of care. This procedure is performed in the
 clinic, patient is positioned on the examining table the same way she is positioned for a
 Papanicolaou (Pap) smear, a speculum is placed inside the vaginal canal, and certain
 substances are applied to the cervix in order to identify cervical lesions. These substances
 might include acetic acid and/or Lugol's iodine solution. The application of these substances
 helps to delineate the abnormal cervical areas that might need to be biopsied. For the
 purpose of this research study, before obtaining the biopsies, a second evaluation will be
 performed using the equipment that is being studied (High- Resolution Microendoscope) and
 using a different substance that will be applied to the cervix. This substance is called
 Proflavine 0.01%. . This second evaluation should not take more than 10 minutes. After
 completing this second evaluation, participants' clinical examination and clinical visit
 should continue as routine.

 The anticipated total number of subjects involved in the study will be 150 women. All these
 anticipated participating women would be from The University of Texas Medical Branch (UTMB),
 Su Clinica and UT Health Science Center (UT-HSC) Mobile Van. The length of time for
 participation is 1 year. However, during the participants' year of enrollment she might have
 only one examination, during one of her visits,using the research equipment.
Inclusion Criteria:

 1. Women with an abnormal Pap test, positive HPV test or any history of cervical
 dysplasia

 2. Women with an intact cervix (patients who have undergone previous LEEP, cone and/or
 cryotherapy are eligible)

 3. Women of childbearing potential must have a negative urine or serum pregnancy test

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

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

 6. For patients that present to clinic to have a cervical excisional procedure (LEEP) for
 an already confirmed diagnosis of high grade cervical dysplasia, HRME imaging study
 will be performed and cervical biopsies might be taken for research purposes only.
 Since these patients have already the confirmed diagnosis of high-grade cervical
 dysplasia, any extra biopsies taken will be for research purposes only and our
 research fund will pay them

 Exclusion Criteria:

 1. Women < 21 years of age

 2. Women who have undergone a hysterectomy with removal of the cervix

 3. Women with a known allergy to proflavine, acriflavine, or iodine

 4. Women who are pregnant or nursing

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