1. Multimodal hyperspectroscopy as a triage test for cervical neoplasia: Pivotal clinical trial results
- Author
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Nahida Chakhtoura, Lisa Flowers, Marc L. Winter, Edward J. Wilkinson, Alexander F. Burnett, Daniel R. Sternfeld, Manocher Lashgari, L.B. Twiggs, Stephen S. Raab, and Daron G. Ferris
- Subjects
Adult ,Optics and Photonics ,medicine.medical_specialty ,Adolescent ,Population ,Uterine Cervical Neoplasms ,Cervical intraepithelial neoplasia ,Young Adult ,Cytology ,Biopsy ,medicine ,Humans ,Prospective Studies ,education ,Papillomaviridae ,Early Detection of Cancer ,Gynecology ,Colposcopy ,education.field_of_study ,medicine.diagnostic_test ,business.industry ,Obstetrics ,Spectrum Analysis ,Papillomavirus Infections ,Obstetrics and Gynecology ,Uterine Cervical Dysplasia ,medicine.disease ,Triage ,Clinical trial ,Spectrometry, Fluorescence ,Oncology ,Dysplasia ,Female ,business - Abstract
Objective To prospectively evaluate a new non invasive device that combines fluorescence and reflectance spectroscopy in a population in women at risk for cervical dysplasia. Methods A total of 1607 women were evaluated with multimodal hyperspectroscopy (MHS), a painless test with extremely high spectral resolution. Subjects who were referred to colposcopy based on abnormal screening tests or other referral criteria underwent the MHS test and also had a sample taken for additional cytology and presence of high risk human papilloma virus (HPV) prior to undergoing biopsy. Results Sensitivity of MHS for cervical intraepithelial neoplasia (CIN) 2+ was 91.3% (252/276). Specificity, or the potential reduction in referrals to colposcopy and biopsy, was 38.9% (222/570) for women with normal or benign histology and 30.3% (182/601) for women with CIN1 histology. Two year follow-up data, collected for a subgroup of 804 women, revealed 67 interval CIN2+ that originally were diagnosed at enrollment as normal or CIN1. MHS identified 60 of these (89.6%) as positive for CIN2+ prior to their discovery during the two year follow-up period. Conclusions MHS provides an immediate result at the point of care. Recently, the limitations of cytology have become more obvious and as a consequence greater emphasis is being placed on HPV testing for cervical cancer screening, creating a need for an inexpensive, convenient and accurate test to reduce false positive referrals to colposcopy and increase the yield of CIN2+ at biopsy. MHS appears to have many of the attributes necessary for such an application.
- Published
- 2013
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