Low-Cost Imaging for Cervical Cancer Prevention in the Texas Lower Rio Grande Valley

2016-03-22 06:23:23 | BioPortfolio


The purpose of this study is to evaluate a different type of medical equipment called "High-Resolution Microendoscope" for the diagnosis of cervical pre-cancerous lesions and cervical cancer. We want to compare the patients' clinical findings using the current equipment that we have in clinic with the clinical findings using the new equipment that we are testing on this research project. If the new equipment is proven to give comparable findings with the current equipment that we are using, 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. You are being asked to participate because you have been diagnosed with an abnormal PAP smear, and you need to have a colposcopic examination to determine the reason for your abnormal PAP smear and receive treatment.


You will start your examination with the colposcopic evaluation using the current equipment as determined by standard of care. But, if cervical biopsies are indicated, before performing your biopsies, for research purposes only- we will:

- Apply a substance called Proflavine 0.01% to your cervix

- We will re-evaluate your cervix with the new equipment we are testing- The High- Resolution Microendoscope

- After completing this re-evaluation, we will continue with the standard of care protocol and will perform your 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 2 of 7 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 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. 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%. Proflavine is a substance that has been used in fluorescent imaging around the world without any adverse effect reported.

This second evaluation should not take more than 10 minutes. After completing this second evaluation, your clinical examination and clinical visit should continue as routine.

There are no known risks associated with the equipment that will be used in this study.

The Food and Drug Administration (FDA) has also determined that the device that we will use during this research study meets the definition of non-significant risk device under the FDA regulations.

The anticipated total number of subjects involved in the study will be 250 women. All these anticipated participating women would be from The University of Texas Medical Branch. The length of time for your participation is 1 year. However, during your year of enrollment you might have only one examination, during one of your visits, using the research equipment.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention


Malignant Neoplasms of Female Genital Organs


Proflavine, High-Resolution Microendoscopy (HRME)


University of Texas Medical Branch Cancer Stop McAllen Clinic
United States


Not yet recruiting


M.D. Anderson Cancer Center

Results (where available)

View Results


Published on BioPortfolio: 2016-03-22T06:23:23-0400

Clinical Trials [1425 Associated Clinical Trials listed on BioPortfolio]

Multimodal Imaging for Surveillance of Patients With Oral Potentially Malignant Disorders

The goal of this clinical research study is to learn if new types of imaging devices can help doctors decide if a lesion in the mouth is pre-cancerous or cancerous.

HRME: Screening for Cervical Cancer and Its Precursors in Low‐Resource Settings

A new mobile diagnostic and treatment unit is being developed by BCH to address the loss-to follow-up associated with the mobile screening program and demonstrate POC diagnosis by HRME. Th...

MRI Imaging of the Human Larynx

To determine if high resolution MRI can detect early invasion of cartilage by laryngeal carcinoma, and to determine if high resolution MRI may be superior to conventional MRI imaging or CT...

18F-FDG PET/MR Imaging for Differentiation of Serous From Non-Serous Pancreatic Cystic Neoplasms: A Pilot Study

The overlap of morphological imaging features results in many incidentally detected pancreatic cystic neoplasms going undiagnosed, including benign serous cystic neoplasms (SCN) and potent...

Transthoracic Sonography Versus High Resolution Computed Tomography in Alveolar Intersitial Syndrome

High resolution computed tomography of the chest is the gold standard imaging modality for most pulmonary diseases. However, the associated high expenses, radiation exposure , and its limi...

PubMed Articles [19203 Associated PubMed Articles listed on BioPortfolio]

Is Proflavine Exposure Associated with Disease Progression in Women with Cervical Dysplasia? A Brief Report.

Proflavine is an acridine dye used with high-resolution microendoscopy for in vivo diagnostic evaluation of cervical epithelial cells. However, there are concerns that even short-term exposure of cerv...

A case report of a concomitant total thyroidectomy and carotid body tumor resection in a 43 year old female.

Carotid body tumors (CBT) are rare neoplasms with relatively; due to their malignant potential, the indicated treatment is surgical resection. There have been described some associations of carotid bo...

Fine-needle Aspiration Cytology to Identify a Rare Mimicker of Breast Cancer: Plasma Cell Mastitis.

There are rare benign diseases that can mimic malignant breast neoplasms in the clinical exam and in mammography. We evaluated the contribution of an accessible procedure to most clinicians, the fine-...

Mucinous Cystadenoma of the Urachus and Review of Current Classification of Urachal Mucinous Cystic Neoplasms.

Urachal neoplasms are uncommon and represent a minor portion of bladder tumors. According to the recently updated World Health Organization classification (2016), these tumors are classified as adenom...

Biliary Mucinous Cystic Neoplasm: a Classic Presentation of a Rare Neoplasm.

Biliary mucinous cystic neoplasms are rare parenchymal neoplasms with a considerable malignant potential. Due to a lack of diagnostic imaging criteria, histopathologic evaluation remains the definitiv...

Medical and Biotech [MESH] Definitions

Tumor or cancer of the female reproductive tract (GENITALIA, FEMALE).

A widely distributed cell surface transmembrane glycoprotein that stimulates the synthesis of MATRIX METALLOPROTEINASES. It is found at high levels on the surface of malignant NEOPLASMS and may play a role as a mediator of malignant cell behavior.

A widely distributed cell surface transmembrane glycoprotein characterized by extracellular IMMUNOGLOBULIN DOMAINS. It stimulates the synthesis of MATRIX METALLOPROTEINASES and is found at high levels on the surface of malignant NEOPLASMS where it may play a role as a mediator of malignant cell behavior.

Neoplasms of the skin and mucous membranes caused by papillomaviruses. They are usually benign but some have a high risk for malignant progression.

New abnormal growth of tissue. Malignant neoplasms show a greater degree of anaplasia and have the properties of invasion and metastasis, compared to benign neoplasms.

More From BioPortfolio on "Low-Cost Imaging for Cervical Cancer Prevention in the Texas Lower Rio Grande Valley"

Quick Search


Relevant Topics

Public Health
Alternative Medicine Cleft Palate Complementary & Alternative Medicine Congenital Diseases Dentistry Ear Nose & Throat Food Safety Geriatrics Healthcare Hearing Medical Devices MRSA Muscular Dyst...

Women's Health
Women's Health - key topics include breast cancer, pregnancy, menopause, stroke Follow and track Women's Health News on BioPortfolio: Women's Health News RSS Women'...

Searches Linking to this Trial