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.
What safety data is available for optical spectroscopy in cervical cancer detection?The safety data for optical spectroscopy in cervical cancer detection indicates that the risks associated with spectroscopic systems are lower than or comparable to those encountered in routine diagnostic procedures like colposcopy. A study comparing the relative risks of UV exposure from fluorescence spectroscopy and colposcopy found that spectroscopic systems pose a similar or lower risk than traditional colposcopy. Additionally, the use of multispectral digital colposcopy and other spectroscopic techniques has been evaluated in pilot studies and clinical trials, suggesting their potential safety and effectiveness for cervical cancer diagnosis.123410
Do I have to stop taking my current medications for this trial?The trial protocol does not specify whether you need to stop taking your current medications.
Is optical spectroscopy a promising treatment for detecting cervical cancer?Yes, optical spectroscopy is a promising treatment for detecting cervical cancer. It is a low-cost and accurate method that can help identify pre-cancerous conditions and cancer in the cervix. This technology uses light to examine the cervix and can be used even in places with limited medical resources. It has shown high accuracy in detecting cervical issues, making it a valuable tool for early diagnosis and treatment.35689
What data supports the idea that Optical Spectroscopy for Cervical Cancer Detection is an effective treatment?The available research shows that Optical Spectroscopy is effective in detecting cervical pre-cancer and cancer. One study found that when used alongside colposcopy, it had a perfect sensitivity of 1.00, meaning it correctly identified all cases of cervical intraepithelial neoplasia (CIN 2 or worse). Its specificity was 0.71, indicating it correctly identified 71% of non-cancer cases. Another study showed that even without colposcopy, the sensitivity was still high at 0.98. These results suggest that Optical Spectroscopy can be as effective as traditional methods like colposcopy, and it might be especially useful in settings with limited resources.35789
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 receiving LEEP for early-stage cervical cancer.
I am having a colposcopy to check for cervical cancer.
Exclusion Criteria
I am a woman under 18 years old.
I am unable to understand and give consent for my own treatment.
Treatment Details
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.
1Treatment groups
Experimental Treatment
Group I: ColposcopeExperimental Treatment3 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
Find a clinic near you
Research locations nearbySelect from list below to view details:
Duke University Medical CenterDurham, NC
Loading ...
Who is running the clinical trial?
Duke UniversityLead Sponsor
References
Safety analysis: relative risks of ultraviolet exposure from fluorescence spectroscopy and colposcopy are comparable. [2019]Fluorescence spectroscopy is a promising tool for use in the diagnosis of disease in human tissue. However, few published reports have evaluated the safety of this technique, despite the fact that many spectroscopic systems use UV illumination. This study determined the relative risk associated with light exposure from spectroscopic systems compared with the traditional light sources that are used to illuminate tissue and direct biopsies. We compared spectroscopic detection systems for the cervix to the colposcope, a low-power microscope routinely used to illuminate the cervix, which does not cause any known photochemical damage. We measured the average spectral irradiance (W/[cm2nm]) and the average tissue exposure time during a diagnostic colposcopy examination. To quantify the relative risks, we multiplied illumination spectra by several action spectra from the literature and compared the areas under the curves corresponding to each procedure. The risk associated with the average power colposcope served as our basis for comparison. We conclude that the risks of illumination using spectroscopic systems are lower than or comparable to those already encountered in routine diagnostic procedures such as colposcopy with an average power colposcope. Spectroscopic examination can be associated with a somewhat higher risk than a colposcopy with the lowest power colposcope or a shorter than average colposcopy. The analysis presented can be repeated to estimate the magnitude of risks associated with other spectroscopic diagnostic devices.
Quality assurance system using statistical process control: an implementation for image cytometry. [2019]Optical technologies have shown some promise for improving the care of cervical neoplasia. We are currently evaluating fluorescence and reflectance spectroscopy and quantitative cyto-histopathology for cervical neoplasia screening and diagnosis. Here we describe the establishment and application of a quality assurance (QA) system for detecting system malfunctions and assessing the comparability of four image cytometers used in a multicenter clinical trial.
Results of a pilot study of multispectral digital colposcopy for the in vivo detection of cervical intraepithelial neoplasia. [2022]Fluorescence spectroscopy is a promising technology for the detection of cervical squamous intraepithelial precancers and cancers. To date, many investigators have focused on point spectroscopy as an adjunct to diagnostic colposcopy. A device that visualizes the whole field of the cervix is needed for screening. To that end, we have developed a multispectral digital colposcope that works through the colposcope to image with white light, UV excitation at 345 nm, and blue light at 440 nm excitation. Here, we report the pilot study that precedes a Phase I trial.
Spectroscopic imaging as a triage test for cervical disease: a prospective multicenter clinical trial. [2008]The objective of the study was to evaluate the potential safety and effectiveness of tissue spectroscopy for the diagnosis of cervical cancer in a prospective multicenter study of women scheduled for colposcopy on the basis of an abnormal Pap test or other risk factor.
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.
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]The clinical utility of spectroscopic methods for the diagnosis of cervical cancer is limited by significant inter-patient variation in the spectroscopic properties of the cervix. Improved understanding of the contributions of the components of cervical tissue to the observed spectra would therefore be helpful in the development of spectroscopic approaches to the study of cervical disease in vivo.
Accuracy of optical spectroscopy for the detection of cervical intraepithelial neoplasia: Testing a device as an adjunct to colposcopy. [2023]Testing emerging technologies involves the evaluation of biologic plausibility, technical efficacy, clinical effectiveness, patient satisfaction, and cost-effectiveness. The objective of this study was to select an effective classification algorithm for optical spectroscopy as an adjunct to colposcopy and obtain preliminary estimates of its accuracy for the detection of CIN 2 or worse. We recruited 1,000 patients from screening and prevention clinics and 850 patients from colposcopy clinics at two comprehensive cancer centers and a community hospital. Optical spectroscopy was performed, and 4,864 biopsies were obtained from the sites measured, including abnormal and normal colposcopic areas. The gold standard was the histologic report of biopsies, read 2 to 3 times by histopathologists blinded to the cytologic, histopathologic, and spectroscopic results. We calculated sensitivities, specificities, receiver operating characteristic (ROC) curves, and areas under the ROC curves. We identified a cutpoint for an algorithm based on optical spectroscopy that yielded an estimated sensitivity of 1.00 [95% confidence interval (CI) = 0.92-1.00] and an estimated specificity of 0.71 [95% CI = 0.62-0.79] in a combined screening and diagnostic population. The positive and negative predictive values were 0.58 and 1.00, respectively. The area under the ROC curve was 0.85 (95% CI = 0.81-0.89). The per-patient and per-site performance were similar in the diagnostic and poorer in the screening settings. Like colposcopy, the device performs best in a diagnostic population. Alternative statistical approaches demonstrate that the analysis is robust and that spectroscopy works as well as or slightly better than colposcopy for the detection of CIN 2 to cancer.
Accuracy of optical spectroscopy for the detection of cervical intraepithelial neoplasia without colposcopic tissue information; a step toward automation for low resource settings. [2022]Optical spectroscopy has been proposed as an accurate and low-cost alternative for detection of cervical intraepithelial neoplasia. We previously published an algorithm using optical spectroscopy as an adjunct to colposcopy and found good accuracy (sensitivity=1.00 [95% confidence interval (CI)=0.92 to 1.00], specificity=0.71 [95% CI=0.62 to 0.79]). Those results used measurements taken by expert colposcopists as well as the colposcopy diagnosis. In this study, we trained and tested an algorithm for the detection of cervical intraepithelial neoplasia (i.e., identifying those patients who had histology reading CIN 2 or worse) that did not include the colposcopic diagnosis. Furthermore, we explored the interaction between spectroscopy and colposcopy, examining the importance of probe placement expertise. The colposcopic diagnosis-independent spectroscopy algorithm had a sensitivity of 0.98 (95% CI=0.89 to 1.00) and a specificity of 0.62 (95% CI=0.52 to 0.71). The difference in the partial area under the ROC curves between spectroscopy with and without the colposcopic diagnosis was statistically significant at the patient level (p=0.05) but not the site level (p=0.13). The results suggest that the device has high accuracy over a wide range of provider accuracy and hence could plausibly be implemented by providers with limited training.
The use of optical spectroscopy for in vivo detection of cervical pre-cancer. [2021]In order to investigate the effectiveness of optical spectroscopy for in vivo diagnosis of cervical pre-cancerous conditions, a series of published studies are surveyed. The six optical technologies investigated include fluorescence spectroscopy, reflectance spectroscopy, and their combination using point probe or multispectral imaging approaches. Searching in the well-known databases, the most recent published works were sought out. Various aspects of the studies were evaluated including the details of the technology used, the pathologic threshold for tissue classification and the gold standard, the study population and prevalence of disease in this population, the method of measurement, the number of clinicians involved in the study, the classification and validation algorithms, and the performance in terms of sensitivity, specificity and, when available, the area under the receiver operating characteristic curve. Forty-four studies conducted from 1994 to 2012 were evaluated. The data are gathered in two comprehensive tables, and five illustrations are provided to simplify a comparison between studies from different points of view. There is a broad band of studies from small pilot studies through phase III clinical trials. Among the reviewed articles, only three factors were found to influence the performance of the optical spectroscopy studies. Multispectral approaches show higher specificity than the point probe approaches (p = 0.001). The use of acetic acid before measurement and prevalence of disease among the studied population, also, have an impact on the sensitivity and specificity of the studies (p
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.