Low-Cost Imaging for Cervical Cancer

Age: 18+

Sex: Female

Trial Phase: Phase < 1

Sponsor: The University of Texas Medical Branch, Galveston

Disqualifiers: Under 21, Hysterectomy, Allergy, Pregnant, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new device called the High-Resolution Microendoscope (HRME) to determine if it can diagnose cervical pre-cancer and cancer as effectively as current methods. The goal is to enable doctors to make quicker treatment decisions without waiting for biopsy results. Women with an abnormal Pap test, a positive HPV test, or a history of cervical dysplasia (abnormal cell growth) might be suitable for this trial. Participants will undergo a special imaging procedure following a standard cervical exam. As an Early Phase 1 trial, this research focuses on understanding how the device functions in people, offering participants a chance to be among the first to benefit from this innovative diagnostic tool.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the High-Resolution Microendoscope (HRME) is safe for diagnosing cervical pre-cancerous lesions?

Research has shown that High-Resolution Microendoscopy (HRME) is generally safe. Past studies used HRME to accurately detect cervical problems and reported no serious side effects, indicating the procedure is well-tolerated. This imaging method uses a special dye called proflavine, applied to the cervix. To date, no major safety concerns have emerged with this technique. HRME could become a reliable way to diagnose cervical issues without requiring multiple doctor visits. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about high-resolution microendoscopy (HRME) for cervical cancer because it offers a new, more detailed way to view cervical cells. Unlike traditional colposcopy, which uses a magnifying device to examine the cervix, HRME involves applying a dye called proflavine to highlight cells and then using high-resolution imaging for a closer look. This method could lead to quicker and more accurate detection of cancerous changes, which is crucial for early intervention. By potentially reducing the need for biopsies and offering immediate results, HRME could make cervical cancer screening more accessible and less invasive.

What evidence suggests that this device is effective for diagnosing cervical cancer?

Studies have shown that High-Resolution Microendoscopy (HRME), the investigational procedure tested in this trial, effectively identifies early signs of cervical cancer. One study showed that HRME correctly identified 86% of cases with pre-cancerous tissue and 87% of cases without it, demonstrating its accuracy in detecting cervical lesions. Another study found a similar result, with HRME detecting 89% of cervical lesions. These findings suggest that HRME could expedite diagnosis, leading to quicker treatment decisions and possibly reducing the wait for biopsy results. ^{1 2 3 5 6}

Who Is on the Research Team?

Kathleen M. Schmeler

Principal Investigator

M.D. Anderson Cancer Center

Ana M Rodriguez, MD

Principal Investigator

University of Texas Medical Branch (UTMB)

Are You a Good Fit for This Trial?

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

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

Exclusion Criteria

I am not pregnant or nursing.

I am allergic to proflavine, acriflavine, or iodine.

I am a woman under 21 years old.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Examination and Imaging

Participants undergo standard colposcopy followed by high-resolution microendoscopy imaging with Proflavine 0.01% application

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the imaging procedure

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• High-Resolution Microendoscopy (HRME)

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.

How Is the Trial Designed?

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+

William Marsh Rice University

Collaborator

Trials

50

Recruited

28,400+

M.D. Anderson Cancer Center

Collaborator

Trials

3,107

Recruited

1,813,000+

The University of Texas Health Science Center, Houston

Collaborator

Trials

974

Recruited

361,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8815862/

Cervical Lesion Assessment using Real-time ... We conducted a prospective evaluation of the diagnostic performance of high-resolution microendoscopy (HRME) to detect cervical intraepithelial neoplasia (CIN)

2. sciencedirect.com sciencedirect.com/science/article/pii/S0895611122000258

Multi-task network for automated analysis of high ... They achieved 89% sensitivity and 54% specificity compared to histopathologic diagnosis (Hunt et al., 2021). In this paper, we present, to our knowledge, the ...

3. journals.plos.org journals.plos.org/plosone/article?id=10.1371/journal.pone.0044924

High-Resolution Microendoscopy for the Detection of Cervical ... Quantitative high resolution imaging achieved a sensitivity and specificity of 86% and 87%, respectively, in differentiating neoplastic (≥CIN 2) tissue from non ...

4. aacrjournals.org aacrjournals.org/cancerpreventionresearch/article/5/11/1273/49939/A-Pilot-Study-of-Low-Cost-High-Resolution

A Pilot Study of Low-Cost, High-Resolution Microendoscopy ... Our long-term hypothesis is that HRME imaging can improve the specificity of early detection of cervical cancer and its precursors by ruling out many of the ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT02206048

Use of High-Resolution Microendoscopy (HRME) in ... The goal of this clinical research study is to learn if it is possible to get high-resolution microendoscopy (HRME) images of AIS tissue and/or tissue from ...

6. prevention.cancer.gov prevention.cancer.gov/clinical-trials/clinical-trials-search/nct02420665

Use of High-Resolution Microendoscopy (HRME) in Patients ... The goal of this clinical research study is to compare a type of imaging called high-resolution microendoscopy (HRME) for detecting abnormal tissue in the ...