Low-Cost Imaging for Cervical Cancer

Overseen by Kathleen M. Schmeler

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase < 1

Waitlist Available

Sponsor: The University of Texas Medical Branch, Galveston

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Research Team

Kathleen M. Schmeler

Principal Investigator

M.D. Anderson Cancer Center

Ana M Rodriguez, MD

Principal Investigator

University of Texas Medical Branch (UTMB)

Eligibility Criteria

This trial is for women over 21 with an intact cervix who have had abnormal Pap tests, positive HPV tests, or a history of cervical dysplasia. It includes those who've had treatments like LEEP, cone, or cryotherapy. Pregnant or nursing women and those allergic to proflavine or iodine can't join.

Inclusion Criteria

Ability to understand and the willingness to provide informed consent and sign a written Informed Consent Document (ICD)

I am a woman with an intact cervix, even if I've had certain cervical procedures.

I have had an abnormal Pap test, a positive HPV test, or a history of cervical dysplasia.

Exclusion Criteria

I am not pregnant or nursing.

I am allergic to proflavine, acriflavine, or iodine.

I am a woman under 21 years old.

Treatment Details

Interventions

• High-Resolution Microendoscopy (HRME) (Other)

Trial Overview The study is testing the High-Resolution Microendoscope (HRME) against current clinical equipment for diagnosing cervical pre-cancer and cancer. The goal is to see if HRME can provide immediate diagnosis without waiting for biopsy results.

Participant Groups

Group I: High-Resolution Microendoscopy (HRME) Experimental Treatment 2 Interventions

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.

Who Is Running the Clinical Trial?

The University of Texas Medical Branch, Galveston

Lead Sponsor

Trials

263

Recruited

55,400+

Dr. Vicente Resto

The University of Texas Medical Branch, Galveston

Chief Medical Officer since 2024

MD from Harvard Medical School

Dr. Jochen Reiser

The University of Texas Medical Branch, Galveston

Chief Executive Officer since 2023

MD, PhD from Ruprecht Karls University of Heidelberg, Germany

William Marsh Rice University

Collaborator

Trials

50

Recruited

28,400+

M.D. Anderson Cancer Center

Collaborator

Trials

3,107

Recruited

1,813,000+

Dr. Peter WT Pisters

M.D. Anderson Cancer Center

Chief Executive Officer since 2017

MD from University of Western Ontario

Dr. Jeffrey E. Lee

M.D. Anderson Cancer Center

Chief Medical Officer

MD from Stanford University School of Medicine

The University of Texas Health Science Center, Houston

Collaborator

Trials

974

Recruited

361,000+

Dr. LaTanya Love

The University of Texas Health Science Center, Houston

Interim President

MD from UT Medical Branch in Galveston

Dr. Jagat Narula

The University of Texas Health Science Center, Houston

Chief Academic Officer since 2023

MD, PhD