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Low-Cost Imaging for Cervical Cancer

Phase < 1
Waitlist Available
Led By Ana M Rodriguez, MD
Research Sponsored by The University of Texas Medical Branch, Galveston
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Women with an abnormal Pap test, positive HPV test, or any history of cervical dysplasia
Women of childbearing potential must have a negative urine or serum pregnancy test
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 day
Awards & highlights

Study Summary

This trial is testing a new type of medical equipment to see if it's as effective as the current equipment in diagnosing cervical pre-cancerous lesions and cancer. If it is, it could mean that patients wouldn't have to wait for biopsy results before getting treatment.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
There may be minimal side effects related to the use of Proflavine during imaging such as mild irritation. However, specific side effects are not detailed in this summary.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have had an abnormal Pap test, a positive HPV test, or a history of cervical dysplasia.
Select...
I am a woman who can have children and have a negative pregnancy test.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 day
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 day for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Diagnostic Accuracy of the High-Resolution Microendoscopy (HRME)

Trial Design

1Treatment groups
Experimental Treatment
Group I: High-Resolution Microendoscopy (HRME)Experimental Treatment2 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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Proflavine
FDA approved

Find a Location

Who is running the clinical trial?

The University of Texas Medical Branch, GalvestonLead Sponsor
246 Previous Clinical Trials
56,650 Total Patients Enrolled
William Marsh Rice UniversityOTHER
45 Previous Clinical Trials
27,795 Total Patients Enrolled
M.D. Anderson Cancer CenterOTHER
2,986 Previous Clinical Trials
1,789,364 Total Patients Enrolled

Media Library

High-Resolution Microendoscopy (HRME) (Other) Clinical Trial Eligibility Overview. Trial Name: NCT02714439 — Phase < 1
Cervical Cancer Research Study Groups: High-Resolution Microendoscopy (HRME)
Cervical Cancer Clinical Trial 2023: High-Resolution Microendoscopy (HRME) Highlights & Side Effects. Trial Name: NCT02714439 — Phase < 1
High-Resolution Microendoscopy (HRME) (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02714439 — Phase < 1
~17 spots leftby Jul 2025
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