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

• Status: Active, not recruiting
• Trial end date: 2022-07-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center; The University of Texas Medical Branch, Galveston
• Collaborators: M.D. Anderson Cancer Center; The University of Texas Health Science Center, Houston; University of Texas; William Marsh Rice University
• Treatments: Proflavine

Criteria

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)