Fear of the speculum and feelings of vulnerability during the gynecologic exams are two of the biggest barriers to cervical cancer screening for women. To address these barriers, we have developed a novel, low-cost tool called the Callascope to reimagine the gynecological exam, enabling clinician and self-imaging of the cervix without the need for a speculum. The Callascope contains a 2 megapixel camera and contrast agent spray mechanism housed within a form factor designed to eliminate the need for a speculum during contrast agent administration and image capture. Preliminary bench testing for comparison of the Callascope camera to a $20,000 high-end colposcope demonstrated that the Callascope camera meets visual requirements for cervical imaging. Bench testing of the spray mechanism demonstrates that the contrast agent delivery enables satisfactory administration and cervix coverage. Clinical studies performed at Duke University Medical Center, Durham, USA and in Greater Accra Regional Hospital, Accra, Ghana assessed (1) the Callascope’s ability to visualize the cervix compared to the standard-of-care speculum exam, (2) the feasibility and willingness of women to use the Callascope for self-exams, and (3) the feasibility and willingness of clinicians and their patients to use the Callascope for clinician-based examinations. Cervix visualization was comparable between the Callascope and speculum (83% or 44/53 women vs. 100%) when performed by a clinician. Visualization was achieved in 95% (21/22) of women who used the Callascope for self-imaging. Post-exam surveys indicated that participants preferred the Callascope to a speculum-based exam. Our results indicate the Callascope is a viable option for clinician-based and self-exam speculum-free cervical imaging. Clinical study registration ClinicalTrials.gov https://clinicaltrials.gov/ct2/show/record/ NCT00900575, Pan African Clinical Trial Registry (PACTR) https://www.pactr.org/ PACTR201905806116817.

We apply feature-extraction and machine learning methods to multiple sources of contrast (acetic acid, Lugol's iodine and green light) from the white Pocket Colposcope, a lowcost point of care colposcope for cervical cancer screening. We combine features from the sources of contrast and analyze diagnostic improvements with addition of each contrast. We find that overall AUC increases with additional contrast agents compared to using only one source. Clinical Relevance-This establishes that development of algorithms for automated colposcopy may benefit from combining multiple sources of contrast. The Pocket colposcope is a low-cost tool that can capture all three standard-of-care sources of contrast. This technology has the potential to provide automated diagnosis of cervical pre-cancer in the hands of nonexperts.

Objective and Impact Statement. We use deep learning models to classify cervix images—collected with a low-cost, portable Pocket colposcope—with biopsy-confirmed high-grade precancer and cancer. We boost classification performance on a screened-positive population by using a class-balanced loss and incorporating green-light colposcopy image pairs, which come at no additional cost to the provider. Introduction. Because the majority of the 300,000 annual deaths due to cervical cancer occur in countries with low- or middle-Human Development Indices, an automated classification algorithm could overcome limitations caused by the low prevalence of trained professionals and diagnostic variability in provider visual interpretations. Methods. Our dataset consists of cervical images (n=1,760) from 880 patient visits. After optimizing the network architecture and incorporating a weighted loss function, we explore two methods of incorporating green light image pairs into the network to boost the classification performance and sensitivity of our model on a test set. Results. We achieve an area under the receiver-operator characteristic curve, sensitivity, and specificity of 0.87, 75%, and 88%, respectively. The addition of the class-balanced loss and green light cervical contrast to a Resnet-18 backbone results in a 2.5 times improvement in sensitivity. Conclusion. Our methodology, which has already been tested on a prescreened population, can boost classification performance and, in the future, be coupled with Pap smear or HPV triaging, thereby broadening access to early detection of precursor lesions before they advance to cancer.

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