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

August 8, 2023 updated by: The University of Texas Medical Branch, Galveston
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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

150

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • McAllen, Texas, United States, 78501
        • University of Texas Medical Branch Cancer Stop McAllen Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: High-Resolution Microendoscopy (HRME)
After standard colposcopy examination performed, participants undergo a high-resolution microendoscopy imaging procedure. Proflavine 0.01% is applied to the cervix, then high-resolution microendoscopy imaging procedure performed. Standard colposcopy procedure will then continue.
Drug: Proflavine
Proflavine 0.01% applied to the cervix before high-resolution microendoscopy imaging procedure performed.
Other Names:
  • Proflavine hemisulfate
Procedure: High-Resolution Microendoscopy (HRME)
High-resolution microendoscopy imaging procedure performed after colposcopy exam. Standard colposcopy procedure will then continue. Entire HRME imaging procedure should add less than 10 minutes to the standard colposcopy exam.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic Accuracy of the High-Resolution Microendoscopy (HRME)
Time Frame: 1 day
Successful outcome defined as concordance between the diagnosis using HRME imaging and the most severe histologic diagnosis.
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Texas Medical Branch, Galveston

Collaborators

M.D. Anderson Cancer Center
The University of Texas Health Science Center, Houston
William Marsh Rice University

Investigators

  • Principal Investigator: Ana M Rodriguez, MD, University of Texas Medical Branch (UTMB)
  • Principal Investigator: Kathleen Schmeler, MD, M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 25, 2016

Primary Completion (Estimated)

July 1, 2025

Study Completion (Estimated)

July 1, 2025

Study Registration Dates

First Submitted

March 16, 2016

First Submitted That Met QC Criteria

March 16, 2016

First Posted (Estimated)

March 21, 2016

Study Record Updates

Last Update Posted (Actual)

August 9, 2023

Last Update Submitted That Met QC Criteria

August 8, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0014-0302
  • NCI-2016-00729 (Registry Identifier: NCI CTRP)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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