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Artificial Intelligence in Health                                   Early detection of CIN/cervicitis using ML



            images, with reference to the pseudocolor intensity maps   for clarity, and if required, the images were recaptured. The
            of autofluorescence and the DR images displayed on the   imaging of the entire cervix enabled clinicians to identify
            screen. The software detected and marked the site with the   the optimal areas for further investigation.
            highest ratio value in the abnormal area or ROI. A biopsy   The  cervical  smear  was  collected  from  the  patients
            was obtained from this site, and the results were correlated   referred for Pap smear testing using a cervical broom and
            with the histopathology findings.                  sent for cytology examination. Women with clinically
              Before the initiation of the imaging procedure, the   suspected cervical malignancy underwent either a
            camera sensor was calibrated to the ambient light conditions   conventional or colposcopy-guided cervical biopsy.
            using a tissue phantom. The device was positioned at a   The site for the biopsy was decided based on the visual
            working distance of 15 cm from the tissue phantom, and   impression and the gynecologist’s experience. The cervix
            the calibration icon in the software was clicked. The four   was anatomically labeled using clock positions, with the
            sets of LEDs blinked sequentially until the calibration was   anterior tip at the 12 o’clock position and the posterior tip
            successfully completed. During the calibration process, the   at the 6 o’clock position. The cervical arteries and veins
            shutter speed of the imaging camera was adjusted relative   run parallel in 3 and 9 o’clock positions, and biopsies were
            to the LED intensity to accommodate the dark room   generally avoided in this area.
            conditions to provide the same levels of image contrast,   2.4. Data processing
            as verified in the captured image following the calibration
            procedure. A  calibration window appeared after the   Figure  2 illustrates the data processing workflow of
            calibration was successfully completed. The device needs   CerviScan. In the first step, the camera captured four
            to be recalibrated when there is a change in the room light   monochrome images. In the pre-processing step, the
            intensity.                                         software created pixel-by-pixel ratio images of DR-recorded
                                                               images (R610/R545 and R610/R575). The PCMs of these
            2.2. Study design and patient enrollment           ratio images, along with the PCM of the F375 (fluorescence)
            The  clinical  study  was conducted at the  Department of   image,  were  displayed  from  blue  to  red, with increasing
            Obstetrics and Gynecology, Kasturba Medical College,   grades of malignancy. For feature extraction, the areas of the
            Manipal, India, after obtaining approval from the   cervix with clinical significance were identified by adjusting
            Institutional Ethics Committee (Ref no.  152/2020). This   the color bar in the PCM image of tissue autofluorescence
            trial was also registered with the Clinical Trial Registry of   and the DR ratio image (R610/R545), followed by marking
            India (REF/2020/08/036212).                        the ROI on either the fluorescence or DR ratio images. In
                                                               the post-processing, the software identified the highest ratio
              Study participants were enrolled according to the   value in the marked ROI for abnormal tissues and an average
            study’s inclusion criteria. Women who were referred   of the values for normal tissue. The program identified the
            for a Pap smear test and those with clinically suspicious   most malignant site within the ROI by locating the pixel
            lesions in their cervix were included in the study. Women   with the highest ratio value.
            with transmittable diseases and those who had previously
            received treatment for cervical cancer were excluded from   3. Results
            the  study.  Signed  informed  consent  was  obtained  from   A total of 109 patients were recruited for this study. Out
            all participants before the initiation of any examination   of the study population, 42 patients with histopathology
            procedures.                                        results were included in the analysis (Table A1). The results
                                                               of histopathology and cytology were correlated with the
            2.3. Data acquisition
                                                               R610/R545 ratio values of the biopsy site. The patients who
            The patient was asked to lie down in the supine lithotomy   underwent hysterectomy following a negative Pap smear
            position. After cleaning the vaginal area with a soft cotton   test were also included as healthy subjects. The results
            swab, the gynecologist inserted a speculum for proper   of histopathology or cytology were correlated with the
            visualization of the cervix. A colored photo of the cervix   R610/R545 ratio values of the biopsy sites. The processed
            was taken as a reference. The CerviScan device was held   DR image ratio R610/R575 was analyzed to discriminate
            steadily and moved back and forth to obtain a focused   cervicitis from normal tissues.
            image on the screen. The capture switch on the device
            was pressed, and four monochrome images of the cervix   3.1. Case studies
            were  recorded  and  stored  in  the  computer  following   The severity of the disease in the cervix was assessed based
            sequential illumination at 370 nm, 545 nm, 575 nm, and   on the percentage increase in the DR ratio R610/R545
            610 nm wavelengths. The captured images were reviewed   value compared to that of the normal cervix. Low DR


            Volume 2 Issue 3 (2025)                        128                               doi: 10.36922/aih.8527
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