Optical Spectroscopy for Cervical Cancer Detection

Recruiting in Palo Alto (17 mi)

Overseen by Nimmi Ramanujam, Ph.D.

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Duke University

Disqualifiers: Minors, Recent bleeding, Preterm labor, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

The objective of the work described in this protocol is to determine the optical signatures of cervical dysplasia using optical technologies.

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 Optical Spectroscopy Bench-Top System for cervical cancer detection?

Research shows that optical spectroscopy, when used alongside colposcopy, has a high sensitivity of 1.00 and a specificity of 0.71 for detecting cervical intraepithelial neoplasia, which are precancerous changes in the cervix. This suggests it can accurately identify cervical changes that may lead to cancer, making it a promising tool for cervical cancer detection. ^{1 2 3 4 5}

Is optical spectroscopy safe for use in humans?

Research shows that the risks of using spectroscopic systems for cervical examination are lower than or similar to those of routine procedures like colposcopy, which is considered safe and does not cause known damage. ^{3 6 7 8 9}

How does optical spectroscopy differ from other treatments for cervical cancer detection?

Optical spectroscopy is unique because it uses light to detect changes in cervical tissue, offering a non-invasive and potentially low-cost alternative to traditional methods like biopsies. It can be used with or without colposcopy (a procedure to closely examine the cervix), making it suitable for low-resource settings and allowing for automation in diagnosis. ^{1 3 4 5 10}

Research Team

Nimmi Ramanujam, Ph.D.

Principal Investigator

Duke University

Eligibility Criteria

This trial is for women undergoing colposcopy, LEEP procedures, or follow-up Pap smears for cervical cancer diagnosis and treatment. It's not open to those under 18, anyone unable to consent, or patients with recent bleeding or preterm labor.

Inclusion Criteria

I am having a colposcopy to check for cervical cancer.

I am receiving LEEP for early-stage cervical cancer.

I need a follow-up Pap smear for monitoring.

Exclusion Criteria

I am a woman under 18 years old.

I am unable to understand and give consent for my own treatment.

Patients with a recent episode of bleeding or preterm labor

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Procedure

Participants undergo optical spectroscopy to determine optical signatures of cervical dysplasia

Less than 10 minutes

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the procedure

4 weeks

Treatment Details

Interventions

• Optical Spectroscopy Bench-Top System (Optical Technology)
• Portable Optical Spectrometer (Optical Technology)
• Transvaginal Colposcope (Optical Technology)

Trial Overview The study is testing optical technologies like a bench-top system, portable spectrometer, and transvaginal colposcope to identify the unique optical patterns of precancerous changes in the cervix.

Participant Groups

Group I: Colposcope Experimental Treatment 3 Interventions

Patients referred for GYN procedures. Specifically, patients will be referred for Pap smear, colposcope or LEEP. The intervention for this arm is the use of the bench-top, miniature optical spectrometer or trans-vaginal colposcope

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+

Mary E. Klotman

Duke University

Chief Executive Officer since 2017

MD from Duke University School of Medicine

Michelle McMurry-Heath

Duke University

Chief Medical Officer since 2020

MD from Duke University School of Medicine

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]

A study involving 1,850 patients and 4,864 biopsies found that an optical spectroscopy algorithm achieved a sensitivity of 100% and a specificity of 71% for detecting CIN 2 or worse, indicating it is highly effective as an adjunct to colposcopy.

The optical spectroscopy method performed similarly to colposcopy in diagnostic settings, suggesting it could be a reliable tool for improving cervical cancer detection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Accuracy of optical spectroscopy for the detection of cervical intraepithelial neoplasia: Testing a device as an adjunct to colposcopy. Cantor, SB., Yamal, JM., Guillaud, M., et al.[2023]

The multispectral digital colposcope (MDC) developed for cervical cancer detection shows promise in visualizing precancerous lesions using different light excitations, with images correlating well to histopathological findings in a pilot study of 46 patients.

The study indicates that the MDC can effectively differentiate between normal and abnormal cervical tissues, with potential for improved screening methods, leading to a planned Phase I trial for further evaluation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Results of a pilot study of multispectral digital colposcopy for the in vivo detection of cervical intraepithelial neoplasia. Milbourne, A., Park, SY., Benedet, JL., et al.[2022]

Optical spectroscopy, including fluorescence and reflectance techniques, shows promise for diagnosing cervical pre-cancerous conditions, with 44 studies reviewed from 1994 to 2012 highlighting its effectiveness.

Multispectral imaging approaches provide higher specificity compared to point probe methods, and factors like the use of acetic acid and disease prevalence significantly influence the sensitivity and specificity of the diagnostic results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The use of optical spectroscopy for in vivo detection of cervical pre-cancer. Hariri Tabrizi, S., Aghamiri, SM., Farzaneh, F., et al.[2021]

The study developed a colposcopy-independent optical spectroscopy algorithm for detecting cervical intraepithelial neoplasia (CIN), achieving a high sensitivity of 0.98 and a specificity of 0.62, indicating it can effectively identify patients with significant lesions.

The results suggest that this optical spectroscopy method could be used by healthcare providers with limited training, making it a promising low-cost alternative for cervical cancer screening.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Accuracy of optical spectroscopy for the detection of cervical intraepithelial neoplasia without colposcopic tissue information; a step toward automation for low resource settings. Yamal, JM., Zewdie, GA., Cox, DD., et al.[2022]

Cervical spectroscopy demonstrated a high sensitivity of 95.1% for detecting moderate and high-grade dysplasia in a study of 572 women, indicating its effectiveness as a diagnostic tool.

The test was well tolerated with no adverse events reported, and it showed a specificity of 55.2% for benign lesions, suggesting it can help reduce false positives in cervical cancer screening.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spectroscopic imaging as a triage test for cervical disease: a prospective multicenter clinical trial. DeSantis, T., Chakhtoura, N., Twiggs, L., et al.[2008]

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]

Fluorescence spectroscopy for diagnosing diseases in human tissue poses a relative risk that is lower than or comparable to traditional colposcopy, which is a common diagnostic tool for examining the cervix.

The study measured light exposure and found that while spectroscopic systems may carry a slightly higher risk than the lowest power colposcopes, they are generally safe for use in diagnostic procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety analysis: relative risks of ultraviolet exposure from fluorescence spectroscopy and colposcopy are comparable. Brookner, CK., Agrawal, A., Trujillo, EV., et al.[2019]

A quality assurance (QA) system was successfully established to monitor and ensure the performance of four image cytometers used in a multicenter clinical trial for cervical neoplasia screening, demonstrating good consistency in daily measurements and comparability among devices.

The QA system effectively detected malfunctions, leading to timely corrections, which is crucial for maintaining data integrity in clinical trials and ensuring reliable results in the evaluation of optical technologies for cervical neoplasia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quality assurance system using statistical process control: an implementation for image cytometry. Chiu, D., Guillaud, M., Cox, D., et al.[2019]

This study used an in vitro model with organotypic epithelial raft cultures to analyze the fluorescence properties of cervical tissue, revealing significant differences in spectral shapes associated with cervical dysplasia.

The application of acetic acid was found to affect fluorescence intensity, which aligns with its clinical use during colposcopy, suggesting that these fluorescence changes could help in identifying cervical lesions more effectively in vivo.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fluorescence spectroscopy of an in vitro model of human cervical neoplasia identifies graded spectral shape changes with neoplastic phenotype and a differential effect of acetic acid. Karadaglić, D., Wood, AD., McRobbie, M., et al.[2014]

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

Accuracy of optical spectroscopy for the detection of cervical intraepithelial neoplasia: Testing a device as an adjunct to colposcopy. [2023]

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

Results of a pilot study of multispectral digital colposcopy for the in vivo detection of cervical intraepithelial neoplasia. [2022]

4. England pubmed.ncbi.nlm.nih.gov

The use of optical spectroscopy for in vivo detection of cervical pre-cancer. [2021]

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

Accuracy of optical spectroscopy for the detection of cervical intraepithelial neoplasia without colposcopic tissue information; a step toward automation for low resource settings. [2022]

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

Spectroscopic imaging as a triage test for cervical disease: a prospective multicenter clinical trial. [2008]

7. Germany pubmed.ncbi.nlm.nih.gov

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

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

Safety analysis: relative risks of ultraviolet exposure from fluorescence spectroscopy and colposcopy are comparable. [2019]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Quality assurance system using statistical process control: an implementation for image cytometry. [2019]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Fluorescence spectroscopy of an in vitro model of human cervical neoplasia identifies graded spectral shape changes with neoplastic phenotype and a differential effect of acetic acid. [2014]