Slide 1: Abnormal Spectroscopy Scans May Presage Persistent or Progressive Cervical Dysplasia
Abnormal Spectroscopy Scans May Presage Persistent or Progressive Cervical Dysplasia Leo B. Twiggs, M.D. Professor Emeritus University of Miami Miller School of Medicine Miami Florida USA Currently- Women’s Cancer and Surgical Care Albuquerque New Mexico USA
Slide 2: Acknowledgements and Disclaimer
Acknowledgements and Disclaimer U.S. and Canadian Clinical Trials partially supported by U.S. National Cancer Institute Presenter and Principal Investigators do not have a financial interest in this project
Slide 3: Clinical Challenge of persistent HPV infection
Clinical Challenge of persistent HPV infection • Usual diagnosis CIN1-Cytologic and Histologic • Prognosis: – Most regress (60% to 80% depending on patient’s age) – Some (about 10% to 20%) persist from year to year causing multiple call backs and interventions – Some (about 10% to 20%) progress to C
Slide 4: Current Status of Prognostic Indicators
Current Status of Prognostic Indicators • Currently no known test can reliably predict progression of CIN1 to more severe disease (CIN2/3) • Evidence from small studies indicates that negative immuno-histochemical staining for tests that assess cell kinetics may be associated with spontaneous regres
Slide 5: Multimodal Cervical Spectroscopy as a Method for Cervical Neoplasia Detection
Multimodal Cervical Spectroscopy as a Method for Cervical Neoplasia Detection • Biochemistry: Fluorescence 300-500 nm excitation – NADH, FAD, Tryptophan – Collagen, Elastin – Porphyrin • Morphology: Reflectance 350-900 nm – Increase in Nuclear/Cytoplasmic ratio – Hyperchromasia – Loss of cellular di
Slide 6: LuViva Advanced Cervical Scan
LuViva® Advanced Cervical Scan • Measures fluorescence and reflectance spectra • Easy to operate with touch screen interface • Single use disposable, Cervical Guide (CG) • Provides an immediate result • Developed by Guided Therapeutics, Inc. Norcross, Georgia, USA
Slide 7: LuViva Cervical Guide
LuViva® Cervical Guide RFID Chip Calibration cap • Single-use patient interface • Attaches to Handheld Unit • Calibrates spectrograph prior to each test • Maintains optical distance and blocks ambient light • RFID Chip assures patient protection by prohibiting use on next patient
Slide 8: Scan Procedure
Scan Procedure • Activate calibration and internal quality checks • Prep subject for gynecological exam – Remove excessive blood or mucus, nothing is applied • Using real-time video imaging, insert CG through speculum until contact is made with cervix • Initiate scan – Capture video image – Collect
Slide 9: Precursors to Invasive Cervical Cancer
Precursors to Invasive Cervical Cancer Spectroscopy light penetrates below surface layer
Slide 10: Spectral Output of Cervical Tissue
Spectral Output of Cervical Tissue Squamous Normal (SN) = Blue Squamocolumnar junction (TZ) = Green High Grade Dysplasia (HG) = Red
Slide 11: US Pivotal Study
US Pivotal Study • 1607 total enrolled to study effectiveness of cervical spectroscopy in triaging women referred to colposcopy based on abnormal Pap/HPV • 195 excluded (mostly training cases or women with discordant or insufficient histopathology) • 1447 analyzed for sensitivity and specificity • S
Slide 12: Pivotal Study Design
Pivotal Study Design • Each subject served as own control • Referral Pap/HPV or other risk factor to qualify for study • Day of study, each subject had endocervical samples taken for Pap and HPV, followed by colposcopy and biopsy • Histology QA procedure used to reach diagnosis for each subject • Fo
Slide 13: Study Design Flow Chart
Study Design Flow Chart Subject Had Referral Pap and was Scheduled for Colposcopy Dysplasia Pap •ASC-H •LSIL ASC-US Pap •AGC Other Factors •Repeat ASC-US •Previous CIN •HPV Positive •Recurrent Changes •W/Risk Factors •Other Risk Factors Study Procedure 1) Cervical Spectroscopy 2) Sample taken for Pa
Slide 14: Dysplasia Progression Study Subgroup
Dysplasia Progression Study Subgroup 804 women returned for follow up per management guidelines: • 222* women with abnormal screening tests leading to colposcopy and biopsy on the day of cervical spectroscopy scan • Consensus pathology results-222 pts : – 89 with CIN1 – 46 free of CIN1, 2 or 3 (norm
Slide 15: Progression Study Subject Histopathology by Age
Progression Study Subject Histopathology by Age Total Age Normal CIN1 Studied 16-20 4 13 17 21-30 12 26 38 31-over 30 50 80 TOTAL 135
Slide 16: Chi Square Results
Chi Square Results Table 1. Chi-square table for women with CIN1 histology at initial visit (p = 0.012) Follow-up Histology % Abnormal Initial Spectroscopy Scans Normal 62.1 (18/29) CIN1 86.0 (37/43) CIN2+ 94.1 (16/17) Table 2. Chi-square table for women with Normal histology at initial visit (p = n
Slide 17: Explanation of Chi Square Results
Explanation of Chi Square Results • Women with CIN1 on the day of their cervical spectroscopy scan were significantly more likely to progress to CIN2/3 within two years if their spectroscopy scan was abnormal • Women without dysplasia on the day of their cervical spectroscopy scan were not significa
Slide 18: Study Caveats
Study Caveats • Some CIN2/3 may have been missed by colposcopically directed biopsy on the day of the spectroscopic scan and therefore do not represent progression • Study population was small • Unable to assess whether women with CIN2 progressed to CIN3 because CIN2 was treated
Slide 19: Conclusions
Conclusions • Cervical spectroscopy is a simple to use test that gives immediate feedback regarding the metabolic and structural changes relating to cervical neoplasia • Pending confirmatory studies, the existing triage use for cervical spectroscopy as an indicator of whether colposcopy is needed ma
Slide 20: Thank You
Thank You WJ Health | sater scrico: UNIVERSITY OF MIAMI HEALTH SYSTEM. of MEDICINE