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

NCT02714439 · Status: TERMINATED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 157

Last updated 2025-01-15

No results posted yet for this study

Summary

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.

Conditions

  • Malignant Neoplasms of Female Genital Organs

Interventions

DRUG

Proflavine

Proflavine 0.01% applied to the cervix before high-resolution microendoscopy imaging procedure performed.

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.

Sponsors & Collaborators

  • M.D. Anderson Cancer Center

    collaborator OTHER

  • The University of Texas Health Science Center, Houston

    collaborator OTHER

  • William Marsh Rice University

    collaborator OTHER

  • The University of Texas Medical Branch, Galveston

    lead OTHER

Principal Investigators

  • Ana M Rodriguez, MD · University of Texas Medical Branch (UTMB)

  • Kathleen Schmeler, MD · M.D. Anderson Cancer Center

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-10-25
Primary Completion
2024-02-09
Completion
2024-02-09
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02714439 on ClinicalTrials.gov