Multimodal Optical Imaging for Cervical Dysplasia Detection

Recruiting in Palo Alto (17 mi)

+3 other locations

Overseen by Kathleen M. Schmeler

Age: 18 - 65

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Under 25, Over 49, Hysterectomy

No Placebo Group

Trial Summary

What is the purpose of this trial?

The study aims to compare the accuracy of the lateral flow test to detect HPV at the POC with commercially available HPV test and to determine the diagnostic accuracy and reliability of a multimodal optical imaging system to detect cervical dysplasia, with the gold reference standard of histopathology.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Multimodal Optical Imaging for detecting cervical dysplasia?

Research shows that techniques like fluorescence and reflectance spectroscopy, which are part of multimodal optical imaging, have been effective in diagnosing cervical neoplasia (abnormal cell growth) in clinical trials. These methods have demonstrated high diagnostic performance and potential as cost-effective alternatives to standard procedures. ^{1 2 3 4 5}

Is Multimodal Optical Imaging safe for humans?

The studies on High-Resolution Microendoscopy (HRME), a type of Multimodal Optical Imaging, suggest it is safe for use in humans, as it is a non-invasive imaging technique used to detect cervical and colorectal neoplasia (abnormal tissue growth). ^{2 5 6 7 8}

How is the treatment Multimodal Optical Imaging unique for detecting cervical dysplasia?

Multimodal Optical Imaging is unique because it combines techniques like autofluorescence imaging and high-resolution microendoscopy to noninvasively detect cervical dysplasia with high accuracy, even in low-resource settings. This approach provides a cost-effective and efficient alternative to traditional methods like colposcopy, which require more infrastructure and expertise. ^{1 2 3 6 9}

Eligibility Criteria

The PEER Trial: Part 2 is for women aged 30-49 with a positive cervical cancer screening test, an intact cervix, and who are not pregnant. Participants must be able to give informed consent. Women under 30 or over 49, those without a cervix due to hysterectomy, or who are pregnant cannot join.

Inclusion Criteria

I am not pregnant, have a recent negative pregnancy test, and am not breastfeeding.

I have had a positive test for cervical cancer.

I am a woman aged between 25 and 49.

Exclusion Criteria

I have had a total hysterectomy.

I am a woman either younger than 25 or older than 49.

I am not pregnant or breastfeeding.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Enrollment and Initial Assessment

Participants provide informed consent, complete a questionnaire, and undergo initial tests including a rapid urine pregnancy test and self-collection of cervico-vaginal samples.

2 weeks

1 visit (in-person)

Diagnostic Imaging and Sample Collection

Participants undergo pelvic examination, cervical sample collection by healthcare providers, and multimodal imaging using mobile colposcope and HRME.

1-2 weeks

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after diagnostic procedures.

4 weeks

Treatment Details

Interventions

• Multimodal Optical Imaging (Diagnostic Device)

Trial Overview This study tests the accuracy of a lateral flow test for HPV against the GeneXpert HPV test and evaluates how well a multimodal optical imaging system detects cervical dysplasia compared to histopathology (tissue examination).

Participant Groups

Group I: Multi-Modal Optical Imaging Experimental Treatment 1 Intervention

Multi-modal imaging (mobile colposcopy and high resolution imaging) of study participants will be performed during the colposcopy examination. Cervical biopsies will be performed using biopsy forceps per standard protocols.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

M D Anderson Cancer Center Houston, TX

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center Lead Sponsor

Eduardo Mondlane University Collaborator

William Marsh Rice University Collaborator

References

1. United States pubmed.ncbi.nlm.nih.gov

The clinical effectiveness of optical spectroscopy for the in vivo diagnosis of cervical intraepithelial neoplasia: where are we? [2022] In this review, we evaluate the diagnostic efficacy of optical spectroscopy technologies (fluorescence and reflectance spectroscopy) for the in vivo diagnosis of cervical neoplasia using both point probe and multispectral imaging approaches.

2. United States pubmed.ncbi.nlm.nih.gov

Multimodal hyperspectral imaging for the noninvasive diagnosis of cervical neoplasia. [2022] To determine the ability of Multimodal Hyperspectral Imaging (MHI) to noninvasively detect, localize and diagnose cervical neoplasia.

3. United States pubmed.ncbi.nlm.nih.gov

Multispectral digital colposcopy for in vivo detection of cervical cancer. [2019] We present a multispectral digital colposcope (MDC) to measure multispectral autofluorescence and reflectance images of the cervix by using an inexpensive color CCD camera. The diagnostic ability of the MDC was evaluated by application of MDC spectral response to fluorescence and reflectance spectra measured from a large clinical trial. High diagnostic performance was achieved by use of only two excitation wavelengths: 330 and 440 nm. Good quality autofluorescence images of the human cervix were acquired in vivo with the MDC. Automated diagnostic algorithms correctly identified CIN (cervical intraepithelial neoplasia) lesions from MDC fluorescence images. The MDC has the potential to provide a costeffective alternative to standard colposcopy and better direction of biopsies.

4. United States pubmed.ncbi.nlm.nih.gov

The clinical effectiveness of fluorescence and reflectance spectroscopy for the in vivo diagnosis of cervical neoplasia: an analysis by phase of trial design. [2022] In this review, we focus on the pilot, Phase I, II, and III clinical trials of fluorescence spectroscopy, reflectance spectroscopy, and their combination for the in vivo diagnosis of cervical neoplasia using both point probe and multi-spectral imaging approaches. Research groups that have progressed from pilot through Phase II/III clinical trials were analyzed.

5. United States pubmed.ncbi.nlm.nih.gov

The performance of fluorescence and reflectance spectroscopy for the in vivo diagnosis of cervical neoplasia; point probe versus multispectral approaches. [2022] This review evaluates the diagnostic efficacy of fluorescence spectroscopy, reflectance spectroscopy, and their combination that use both point probe and multispectral imaging approaches in diagnosing cervical neoplasia in vivo.

6. United States pubmed.ncbi.nlm.nih.gov

High-resolution microendoscopy for the detection of cervical neoplasia in low-resource settings. [2021] Cervical cancer is the second leading cause of cancer death among women in developing countries. Developing countries often lack infrastructure, cytotechnologists, and pathologists necessary to implement current screening tools. Due to their low cost and ease of interpretation at the point-of-care, optical imaging technologies may serve as an appropriate solution for cervical cancer screening in low resource settings. We have developed a high-resolution optical imaging system, the High Resolution Microendoscope (HRME), which can be used to interrogate clinically suspicious areas with subcellular spatial resolution, revealing changes in nuclear to cytoplasmic area ratio. In this pilot study carried out at the women's clinic of Princess Marina Hospital in Botswana, 52 unique sites were imaged in 26 patients, and the results were compared to histopathology as a reference standard. Quantitative high resolution imaging achieved a sensitivity and specificity of 86% and 87%, respectively, in differentiating neoplastic (≥CIN 2) tissue from non-neoplastic tissue. These results suggest the potential promise of HRME to assist in the detection of cervical neoplasia in low-resource settings.

7. Australia pubmed.ncbi.nlm.nih.gov

In vivo classification of colorectal neoplasia using high-resolution microendoscopy: Improvement with experience. [2018] High-resolution microendoscopy (HRME) is a novel, low-cost "optical biopsy" technology that allows for subcellular imaging. The study aim was to evaluate the learning curve of HRME for the differentiation of neoplastic from non-neoplastic colorectal polyps.

8. United States pubmed.ncbi.nlm.nih.gov

Low-cost, high-resolution imaging for detecting cervical precancer in medically-underserved areas of Texas. [2022] Cervical cancer rates in the United States have declined since the 1940's, however, cervical cancer incidence remains elevated in medically-underserved areas, especially in the Rio Grande Valley (RGV) along the Texas-Mexico border. High-resolution microendoscopy (HRME) is a low-cost, in vivo imaging technique that can identify high-grade precancerous cervical lesions (CIN2+) at the point-of-care. The goal of this study was to evaluate the performance of HRME in medically-underserved areas in Texas, comparing results to a tertiary academic medical center.

9. Germany pubmed.ncbi.nlm.nih.gov

Hyperspectral imaging as a new diagnostic tool for cervical intraepithelial neoplasia. [2023] Cervical cancer screening by visual inspection with acetic acid (VIA) during colposcopy can be challenging and is highly dependent on the clinical experience of the examiner. Health-care systems lack qualified physicians able to perform the examination in both industrialized and low- and middle-income countries. Previous work has shown the general potential of hyperspectral imaging (HSI) to discriminate CIN from normal tissue, but clinical translation has been limited due to the lack of medically approved HSI systems.