Optical Spectroscopy for Cervical Cancer Detection

Overseen By Nimmi Ramanujam, Ph.D.

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Duke University

Disqualifiers: Minors, Recent bleeding, Preterm labor, others

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

Compensation: Varies

Number of Visits: 1

350 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial seeks new methods to detect cervical dysplasia, a change in cervical cells that could lead to cancer. Researchers will use special tools, including an Optical Spectroscopy Bench-Top System and a Portable Optical Spectrometer, to shine light on the cervix and identify these changes. Women undergoing a colposcopy, a follow-up Pap smear, or a LEEP procedure (a treatment for early-stage cervical cancer) might be suitable for this trial. Participation can help improve early detection methods for cervical cancer. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could enhance early detection techniques for cervical cancer.

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 prior data suggests that these optical technologies are safe for cervical cancer detection?

Research shows that the tools used in this trial, such as the Optical Spectroscopy Bench-Top System, are generally easy to handle. Studies have found that optical spectroscopy safely and effectively detects changes in cervical cells. It is non-invasive, requiring no surgery or cutting.

The Portable Optical Spectrometer is reviewed as a low-cost, safe method for detecting cancer. It can be used with devices like smartphones, making it simple to use without causing harm.

The Transvaginal Colposcope is known for its safety. It allows doctors to closely examine the cervix to identify any problems. Commonly used in gynecological exams, it has been safely used for many years.

Overall, these tools are considered safe for use in humans. Various studies have tested them and shown them to be well-tolerated with minimal risk of side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Optical Spectroscopy methods for detecting cervical cancer because these techniques offer a non-invasive and potentially more accurate alternative to traditional methods like Pap smears and colposcopies. Unlike standard procedures that rely on visual examination and biopsy, optical spectroscopy uses light to analyze tissue properties, which could lead to earlier and more precise detection of cancerous changes. Additionally, the portability of the optical spectrometer and the transvaginal colposcope means these tools could be used in a wider range of settings, making cervical cancer screening more accessible to women who might not have access to conventional clinical facilities.

What evidence suggests that these optical spectroscopy systems are effective for cervical cancer detection?

Research has shown that optical spectroscopy can accurately detect early changes in cervical cells that might lead to cancer. Studies suggest it is a promising and affordable way to identify abnormal cell growth, known as cervical intraepithelial neoplasia. In this trial, participants may be assessed using the portable optical spectrometer, which often works with smartphones and shows promise for early detection of cervical cancer. This device is designed to find unique signs indicating early-stage cancer. Alternatively, participants may be assessed using the transvaginal colposcope, which provides a detailed view and is more accurate in spotting cervical lesions than some standard methods. Together, these tools offer hope for more precise and less stressful cervical cancer screening. ^{1 2 3 6 7}

Who Is on the Research Team?

Nimmi Ramanujam, Ph.D.

Principal Investigator

Duke University

Are You a Good Fit for This Trial?

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Optical Spectroscopy Bench-Top System
• Portable Optical Spectrometer
• Transvaginal Colposcope

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3015005/

Accuracy of optical spectroscopy for the detection of cervical ... The objective of this study was to select an effective classification algorithm for optical spectroscopy as an adjunct to colposcopy and obtain preliminary ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3380950/

Accuracy of optical spectroscopy for the detection ... Optical spectroscopy has been proposed as an accurate and low-cost alternative for detection of cervical intraepithelial neoplasia.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT00529464?tab=table

Spectroscopy Versus Standard Care in Cervical Cancer ... To see if optical spectroscopy using both the point probe and the multi-spectral device improves diagnosis by improving specificity over colposcopy alone. To ...

4. acsjournals.onlinelibrary.wiley.com acsjournals.onlinelibrary.wiley.com/doi/full/10.1002/cncr.11678

Optical imaging of the cervix - Drezek - 2003 - Cancer In the current study, we summarize the current research in developing emerging optical technologies for the detection of cervical precancerous ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0002937803005404

Patient distress and satisfaction with optical spectroscopy ... Patients reported less distress during spectroscopy than during a Papanicolaou test, colposcopy, or biopsy suggests the possibility of improved adherence.

6. mdpi.com mdpi.com/1420-3049/28/6/2502

Raman Spectroscopy for Early Detection of Cervical ... This review discusses the research to date on Raman spectroscopic approaches for cervical cancer using exfoliated cells, biofluid samples, and tissue ex vivo ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S246845112300051X

Optical imaging technologies for in vivo cancer detection ... This review explores recent advancements in low-cost optical imaging technologies for in vivo cancer detection in LRS, highlighting benefits, prospects, and ...