Optical Sensor Detection for Oral Diseases

Recruiting at1 trial location

Overseen by Petra Wilder-Smith, DDS, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of California, Irvine

Disqualifiers: Advanced gum disease, untreated cavities, others

No Placebo Group

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

Overall objective of this work is to develop better ways of detecting, diagnosing and measuring oral diseases and structures using light and optical approaches. All different areas of the mouth will be imaged, including healthy, diseased, dysplastic and malignant, as well as oral biofilm, and the imaging data compared against conventional diagnostic approaches such clinical and histopathological and molecular evaluations to (1) gain a better understanding of processes involved in oral pathology and (2) develop a combined patient specific, non-invasive method for the detection, diagnosis and screening of oral pathology and biofilm. Thus our goal is to identify and evaluate microstructural, metabolic, vascular, protein, genomic and metabolomics biomarkers of oral pathology can be used to detect, predict and map oral pathology, especially neoplasia. We are recruiting patients with a wide range of oral conditions including plaque, dry mouth, toothache, root canal treatments, gum disease, oral sores, dysplasia and cancer, autoimmune conditions and others as well as healthy control subjects. We will use a range of non-invasive imaging modalities to obtain information on the ways in which the oral health status affects optical properties, and determine means of detecting and quantifying these factors.. Imaging modalities to be utilized include: 1. Coherence and Doppler Tomography 2. Laser Speckle Imaging 3. Various forms of Spectroscopy 4. Fluorescence

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 is best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment for detecting oral diseases using optical sensors?

Research shows that optical diagnostic tools, like fluorescence spectroscopy, are effective in detecting early signs of oral diseases. These tools are non-invasive, provide real-time results, and have been shown to accurately identify oral lesions, which can help in early diagnosis and treatment. ^{1 2 3 4 5}

Is the optical sensor detection for oral diseases safe for humans?

The optical sensor detection methods for oral diseases are generally considered safe as they are non-invasive, do not use harmful radiation, and are designed to be patient-friendly. ^{2 3 5 6 7}

How is the Optical Sensor Detection for Oral Diseases treatment different from other treatments for oral diseases?

This treatment is unique because it uses optical sensors to detect oral diseases noninvasively, providing real-time, high-resolution images without the need for ionizing radiation. It offers a patient-friendly and repeatable method that can quickly identify changes in oral tissues, potentially improving early diagnosis and management of oral conditions. ^{2 4 8 9 10}

Research Team

Petra Wilder-Smith, DDS, PhD

Principal Investigator

University of Calfornia Irvine

Eligibility Criteria

This trial is for adults over 18, both smokers and non-smokers, with various oral conditions like dry mouth, gum disease, or lesions. It's also open to healthy individuals as controls. People under 18, those with advanced gum disease or untreated cavities, pregnant or breastfeeding women, and immune-compromised individuals cannot participate.

Inclusion Criteria

I am 18 years old or older.

I may or may not have a lesion in my mouth.

I have gum disease.

Exclusion Criteria

I am under 18 years old.

Immune compromised individuals

Pregnant or breastfeeding

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging and Data Collection

Participants undergo non-invasive imaging using modalities such as Coherence and Doppler Tomography, Laser Speckle Imaging, Photon Migration Spectroscopy, and Autofluorescence Imaging. Saliva samples are also collected for analysis.

up to 12 months

Follow-up

Participants are monitored for safety and effectiveness of the imaging modalities and data correlation with oral pathology stages.

4 weeks

Treatment Details

Interventions

• Detection of Oral Pathology (Optical Sensor)

Trial Overview The study aims to develop a new non-invasive method using light-based technologies to detect and diagnose oral diseases. Techniques include Coherence Tomography, Laser Speckle Imaging, Spectroscopy and Fluorescence compared against traditional clinical evaluations.

Participant Groups

Group I: Oral tissue Experimental Treatment 1 Intervention

Imaging of oral structures and pathologies

Detection of Oral Pathology is already approved in China for the following indications:

Approved in China as Photodynamic Diagnosis for:

• Oral leukoplakia
• Oral squamous cell carcinoma

Who Is Running the Clinical Trial?

University of California, Irvine

Lead Sponsor

Trials

580

Recruited

4,943,000+

Chad T. Lefteris

University of California, Irvine

Chief Executive Officer since 2019

MBA from University of California, Irvine

Michael J. Stamos

University of California, Irvine

Chief Medical Officer since 2019

MD, PhD from University of California, Irvine

Livionex Inc.

Industry Sponsor

Trials

4

Recruited

2,800+

Beckman Laser Institute University of California Irvine

Collaborator

Trials

78

Recruited

5,000+

Dr. Bernard Choi

Beckman Laser Institute University of California Irvine

Chief Executive Officer since 2023

PhD in Biomedical Engineering, University of California, Irvine

Dr. J. Stuart Nelson

Beckman Laser Institute University of California Irvine

Chief Medical Officer since 2020

MD from University of California, Irvine

Orahealth

Collaborator

Trials

1

Recruited

2,500+

Livionex Inc

Collaborator

Trials

3

Recruited

2,700+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Dr. Jeanne Marrazzo

National Institutes of Health (NIH)

Chief Medical Officer

MD from University of California, Los Angeles

Dr. Jay Bhattacharya

National Institutes of Health (NIH)

Chief Executive Officer

MD, PhD from Stanford University

National Institute for Biomedical Imaging and Bioengineering (NIBIB)

Collaborator

Trials

102

Recruited

21,600+

Dr. Bruce J. Tromberg

National Institute for Biomedical Imaging and Bioengineering (NIBIB)

Chief Executive Officer since 2019

PhD in Biomedical Engineering from the University of California, Irvine

Dr. Nina F. Schor

National Institute for Biomedical Imaging and Bioengineering (NIBIB)

Chief Medical Officer since 2023

MD from Harvard Medical School

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Dr. Douglas R. Lowy

National Cancer Institute (NCI)

Chief Executive Officer since 2023

MD from New York University School of Medicine

Dr. Monica Bertagnolli

National Cancer Institute (NCI)

Chief Medical Officer since 2022

MD from Harvard Medical School

National Institute of Dental and Craniofacial Research (NIDCR)

Collaborator

Trials

312

Recruited

853,000+

Janice S. Lee

National Institute of Dental and Craniofacial Research (NIDCR)

Clinical Director

DDS, MD, MS

Jennifer Webster-Cyriaque

National Institute of Dental and Craniofacial Research (NIDCR)

Acting Director

DDS, PhD

Findings from Research

A portable spectroscopy device was tested on 79 oral sites from 33 subjects, including 28 patients with oral lesions, showing high accuracy in identifying oral cancer with an area under the curve (AUC) of 0.90 for nonkeratinized sites.

The device also demonstrated good efficacy for keratinized sites, with an AUC of 0.83, indicating its potential as a noninvasive tool for early oral cancer diagnosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prospective evaluation of a portable depth-sensitive optical spectroscopy device to identify oral neoplasia. Schwarz, RA., Gao, W., Stepanek, VM., et al.[2021]

Emerging optical diagnostic tools for the oral cavity offer non-invasive, radiation-free, and patient-friendly options for detecting and diagnosing early diseases, which is crucial as the focus shifts towards disease prevention and reversal.

These technologies provide real-time, high-resolution imaging of both soft and hard tissues, making them valuable for diagnosing oral mucosal lesions and dental pathologies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optical diagnostics in the oral cavity: an overview. Wilder-Smith, P., Holtzman, J., Epstein, J., et al.[2021]

Fluorescence imaging using 5-aminolevulinic acid significantly improves the detection of premalignant and malignant lesions in the oral cavity, with a sensitivity of 83-90% and specificity of 79-89% based on a study of 71 patients.

This technique offers advantages over traditional methods, providing real-time diagnosis and in situ monitoring, making it a more patient-friendly option compared to surgical biopsies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fluorescence spectroscopy combined with 5-aminolevulinic acid-induced protoporphyrin IX fluorescence in detecting oral premalignancy. Sharwani, A., Jerjes, W., Salih, V., et al.[2016]

Fluorescence spectroscopy can effectively differentiate between normal and abnormal oral mucosa, showing significant differences in spectral characteristics between healthy tissue and lesions, with a sensitivity of 88% and specificity of 100% for one diagnostic algorithm.

This noninvasive technique has the potential to enhance the early detection of oral cavity neoplasia, which could lead to better outcomes in managing premalignant and malignant lesions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Noninvasive diagnosis of oral neoplasia based on fluorescence spectroscopy and native tissue autofluorescence. Gillenwater, A., Jacob, R., Ganeshappa, R., et al.[2019]

A prototype optical spectroscopy device using multiple light wavelengths (white, green-amber at 545 nm, and violet at 405 nm) has shown promise in enhancing the detection of oral precancerous lesions compared to standard white light examination in a study involving over 300 patients across two clinical sites.

The device's use of violet light-induced fluorescence and green-amber reflectance improved visualization of lesion characteristics, such as abnormal vasculature and stromal changes, suggesting it could significantly increase the sensitivity of oral cancer screenings when used by healthcare professionals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Has fluorescence spectroscopy come of age? A case series of oral precancers and cancers using white light, fluorescent light at 405 nm, and reflected light at 545 nm using the Trimira Identafi 3000. Lane, P., Follen, M., MacAulay, C.[2020]

Early detection of oral potentially malignant disorders (PMDs) is crucial for preventing the progression to oral squamous cell carcinoma (OSCC), which remains a significant health concern due to high morbidity and mortality rates.

The review evaluates various non-invasive diagnostic techniques, such as vital staining, light-based detection systems, optical technologies, and salivary biomarkers, highlighting their potential effectiveness in screening and monitoring PMDs, along with their sensitivity and specificity for detecting these conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Non-Invasive Techniques for Detection and Diagnosis of Oral Potentially Malignant Disorders. Liu, D., Zhao, X., Zeng, X., et al.[2017]

In a study of 25 patients with oral potentially malignant disorders (OPMDs), toluidine blue staining demonstrated higher sensitivity (91%) and accuracy (75%) compared to the autofluorescence evaluation with GOCCLES®, which had a sensitivity of 66% and accuracy of 53%.

Both diagnostic methods, while effective in identifying dysplastic areas, cannot reliably differentiate between benign and malignant lesions, highlighting the need for further histopathological analysis after initial screening.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Evaluation of the Optical Filter for Autofluorescence Glasses for Oral Cancer Curing Light Exposed (GOCCLES®) in the Management of Potentially Premalignant Disorders: A Retrospective Study. Lajolo, C., Tranfa, M., Patini, R., et al.[2022]

Novel optical-based diagnostic systems can enhance clinical assessments by providing rapid, real-time diagnosis of oral and head and neck lesions, serving as an adjunct to traditional histopathological methods.

These systems utilize different wavelengths of light to detect tissue changes, which can lead to quicker and more accurate identification of lesions, improving patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optical diagnostic systems for assessing head and neck lesions. Green, B., Tsiroyannis, C., Brennan, PA.[2017]

The depth-sensitive optical spectroscopy (DSOS) system demonstrated high diagnostic performance in distinguishing dysplastic and cancerous oral lesions from non-neoplastic tissue, achieving a sensitivity and specificity comparable to expert clinical diagnosis.

In a study involving 124 subjects and 424 oral sites, the DSOS system's algorithms showed an impressive area under the curve of 0.96 in training and 0.93 in validation, indicating its potential as a reliable tool for early oral cancer detection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Noninvasive evaluation of oral lesions using depth-sensitive optical spectroscopy. Schwarz, RA., Gao, W., Redden Weber, C., et al.[2021]

Optical diagnosis techniques for oral cancer, such as fluorescence and Raman spectroscopy, offer advantages like objectivity, speed, and cost-effectiveness, potentially transforming cancer management workflows.

Recent in vivo human clinical studies are exploring the clinical application of these noninvasive methods, highlighting their promise as adjunct tools to traditional diagnostic approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recent advances in optical diagnosis of oral cancers: Review and future perspectives. Singh, SP., Ibrahim, O., Byrne, HJ., et al.[2018]

References

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

Prospective evaluation of a portable depth-sensitive optical spectroscopy device to identify oral neoplasia. [2021]

2. Denmark pubmed.ncbi.nlm.nih.gov

Optical diagnostics in the oral cavity: an overview. [2021]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Fluorescence spectroscopy combined with 5-aminolevulinic acid-induced protoporphyrin IX fluorescence in detecting oral premalignancy. [2016]

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

Noninvasive diagnosis of oral neoplasia based on fluorescence spectroscopy and native tissue autofluorescence. [2019]

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

Has fluorescence spectroscopy come of age? A case series of oral precancers and cancers using white light, fluorescent light at 405 nm, and reflected light at 545 nm using the Trimira Identafi 3000. [2020]

6. Japan pubmed.ncbi.nlm.nih.gov

Non-Invasive Techniques for Detection and Diagnosis of Oral Potentially Malignant Disorders. [2017]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Clinical Evaluation of the Optical Filter for Autofluorescence Glasses for Oral Cancer Curing Light Exposed (GOCCLES®) in the Management of Potentially Premalignant Disorders: A Retrospective Study. [2022]

8. Denmark pubmed.ncbi.nlm.nih.gov

Optical diagnostic systems for assessing head and neck lesions. [2017]

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

Noninvasive evaluation of oral lesions using depth-sensitive optical spectroscopy. [2021]

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

Recent advances in optical diagnosis of oral cancers: Review and future perspectives. [2018]