Multimodal Optical Imaging for Cervical Dysplasia Detection

Recruiting at 3 trial locations

Overseen By Mila Salcedo, MD, PhD

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Under 25, Over 49, Hysterectomy

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

Compensation: Varies

Number of Visits: 3

678 Participants Needed

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}

Research Team

Kathleen M. Schmeler

Principal Investigator

M.D. Anderson Cancer Center

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.

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

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.

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

Eduardo Mondlane University

Collaborator

Trials

10

Recruited

46,600+

William Marsh Rice University

Collaborator

Trials

50

Recruited

28,400+

Findings from Research

Optical spectroscopy technologies, including fluorescence and reflectance spectroscopy, show diagnostic performance comparable to colposcopy for detecting cervical neoplasia, based on a review of 26 studies involving various device approaches and populations.

While optical spectroscopy could potentially aid in localizing lesions and serve as an adjunct to colposcopy, its use for ASCUS triage and primary screening has not been adequately evaluated to confirm its effectiveness in those roles.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The clinical effectiveness of optical spectroscopy for the in vivo diagnosis of cervical intraepithelial neoplasia: where are we? Cardenas-Turanzas, M., Freeberg, JA., Benedet, JL., et al.[2022]

Multimodal Hyperspectral Imaging (MHI) demonstrated a high sensitivity of 97% for detecting cervical neoplasia, significantly outperforming the Pap smear's sensitivity of 72% at the same specificity level of 70%.

The study involved 111 patients and showed that MHI can noninvasively detect and localize cervical cancer precursors more effectively than traditional methods, suggesting it could be a valuable tool in cervical cancer screening.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multimodal hyperspectral imaging for the noninvasive diagnosis of cervical neoplasia. Ferris, DG., Lawhead, RA., Dickman, ED., et al.[2022]

The multispectral digital colposcope (MDC) demonstrated high diagnostic performance for identifying cervical intraepithelial neoplasia (CIN) lesions using only two excitation wavelengths (330 and 440 nm) in a large clinical trial.

The MDC produced good quality autofluorescence images of the cervix in vivo and has the potential to serve as a cost-effective alternative to standard colposcopy, improving biopsy targeting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multispectral digital colposcopy for in vivo detection of cervical cancer. Benavides, J., Chang, S., Park, S., et al.[2019]

A review of 26 clinical trials on fluorescence and reflectance spectroscopy for diagnosing cervical neoplasia found that larger sample sizes and older patient populations (over 50 years) were associated with decreased performance of diagnostic devices.

The study highlighted that as clinical trials progressed from pilot to Phase III, the variability in performance increased, indicating that factors like sample size and patient demographics significantly impact the efficacy of these diagnostic methods.

NCBI (Pubmed)

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. Freeberg, JA., Benedet, JL., West, LA., et al.[2022]

Fluorescence and reflectance spectroscopy, whether used in point probe or multispectral imaging, show similar diagnostic efficacy for detecting cervical neoplasia, based on a review of 26 studies, although definitive conclusions about their combined effectiveness are still unclear.

Most studies focused on diagnostic populations with existing cervical abnormalities, highlighting a lack of research on screening populations, which limits the understanding of these technologies' effectiveness in early detection.

NCBI (Pubmed)

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. Freeberg, JA., Benedet, JL., MacAulay, C., et al.[2022]

The High Resolution Microendoscope (HRME) demonstrated a sensitivity of 86% and specificity of 87% in detecting neoplastic tissue in a pilot study involving 26 patients in Botswana, indicating its effectiveness as a screening tool for cervical cancer.

This optical imaging technology offers a low-cost and easy-to-use alternative for cervical cancer screening in developing countries, where traditional methods may be limited due to lack of resources and trained personnel.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High-resolution microendoscopy for the detection of cervical neoplasia in low-resource settings. Quinn, MK., Bubi, TC., Pierce, MC., et al.[2021]

High-resolution microendoscopy (HRME) significantly improves the ability to differentiate between neoplastic and non-neoplastic colorectal polyps, with diagnostic accuracy increasing from 63% to 96% as the endoscopist gains experience with the technique over 162 polyps.

The study shows that even endoscopists without prior HRME experience can achieve over 90% accuracy in identifying neoplastic polyps after imaging just 40 polyps, indicating HRME's potential as a valuable tool in colorectal cancer screening.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In vivo classification of colorectal neoplasia using high-resolution microendoscopy: Improvement with experience. Parikh, ND., Perl, D., Lee, MH., et al.[2018]

High-resolution microendoscopy (HRME) significantly improved the specificity of detecting high-grade precancerous cervical lesions (CIN2+) compared to traditional colposcopy, with specificity rates of 56% for HRME versus 45% for colposcopy.

The study involved 174 women across various outpatient settings, demonstrating that HRME maintains consistent image quality regardless of the clinical environment or the skill level of the medical providers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low-cost, high-resolution imaging for detecting cervical precancer in medically-underserved areas of Texas. Parra, SG., Rodriguez, AM., Cherry, KD., et al.[2022]

Hyperspectral imaging (HSI) has been shown to effectively differentiate between cervical intraepithelial neoplasia (CIN) and normal tissue in a study involving 41 patients, demonstrating high statistical significance in the results.

The use of commercially available HSI systems could provide a contact-free and examiner-independent method for diagnosing CIN, addressing the shortage of qualified physicians for cervical cancer screening.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hyperspectral imaging as a new diagnostic tool for cervical intraepithelial neoplasia. Schimunek, L., Schöpp, K., Wagner, M., et al.[2023]

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]

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

Multimodal hyperspectral imaging for the noninvasive diagnosis of cervical neoplasia. [2022]

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

Multispectral digital colposcopy for in vivo detection of cervical cancer. [2019]

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]

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]

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

High-resolution microendoscopy for the detection of cervical neoplasia in low-resource settings. [2021]

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

In vivo classification of colorectal neoplasia using high-resolution microendoscopy: Improvement with experience. [2018]

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

Low-cost, high-resolution imaging for detecting cervical precancer in medically-underserved areas of Texas. [2022]

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

Hyperspectral imaging as a new diagnostic tool for cervical intraepithelial neoplasia. [2023]