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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

Must not have

Women who are pregnant or nursing

Women with a known allergy to proflavine, acriflavine, or iodine

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 day

Awards & highlights

All Individual Drugs Already Approved

No Placebo-Only Group

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.

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.

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

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

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I am a woman who can have children and have a negative pregnancy test.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not pregnant or nursing.

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I am allergic to proflavine, acriflavine, or iodine.

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I am unable or unwilling to sign a consent form.

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I am a woman under 21 years old.

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I have had a hysterectomy with my cervix removed.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 day

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Diagnostic Accuracy of the High-Resolution Microendoscopy (HRME)

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 7Eligibility criteria met