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

NCT02714439 | Terminated Early Phase 1 FDA Drug

• 2 other identifiers: 0014-0302NCI-2016-00729
• Study Type: interventional
• Target: 157
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Malignant neoplasms of female genital organs; Cervical Cancer Prevention; Abnormal Pap test; Positive HPV test; History of cervical dysplasia; Colposcopy; Proflavine; Proflavine hemisulfate; High-Resolution Microendoscopy; HRME; Human papillomavirus

Outcome Measures

Primary Outcomes (1)

• Diagnostic Accuracy of the High-Resolution Microendoscopy (HRME)

  Successful outcome defined as concordance between the diagnosis using HRME imaging and the most severe histologic diagnosis.

  1 day

Study Arms (1)

High-Resolution Microendoscopy (HRME)

EXPERIMENTAL

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; Procedure: High-Resolution Microendoscopy (HRME)

Interventions

Proflavine DRUG

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

Also known as: Proflavine hemisulfate

High-Resolution Microendoscopy (HRME)

High-Resolution Microendoscopy (HRME) PROCEDURE

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.

High-Resolution Microendoscopy (HRME)

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women with an abnormal Pap test, positive HPV test or any history of cervical dysplasia
• Women with an intact cervix (patients who have undergone previous LEEP, cone and/or cryotherapy are eligible)
• Women of childbearing potential must have a negative urine or serum 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)
• 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

You may not qualify if:

• Women \< 21 years of age
• Women who have undergone a hysterectomy with removal of the cervix
• Women with a known allergy to proflavine, acriflavine, or iodine
• Women who are pregnant or nursing
• Patients unable or unwilling to provide informed consent or sign a written Informed Consent Document (ICD)

Sponsors & Collaborators

• The University of Texas Medical Branch, Galveston: lead
• M.D. Anderson Cancer Center: collaborator
• The University of Texas Health Science Center, Houston: collaborator
• William Marsh Rice University: collaborator

Study Sites (1)

University of Texas Medical Branch Cancer Stop McAllen Clinic

McAllen, Texas, 78501, United States

Location

Related Links

• University of Texas Medical Branch web site

MeSH Terms

Interventions

Proflavine

Intervention Hierarchy (Ancestors)

Aminoacridines; Acridines; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Ana M Rodriguez, MD

  University of Texas Medical Branch (UTMB)

  PRINCIPAL INVESTIGATOR

• Kathleen Schmeler, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2016
• First Posted: March 21, 2016
• Study Start: October 25, 2016
• Primary Completion: February 9, 2024
• Study Completion: February 9, 2024
• Last Updated: January 15, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)