Multimodal hyperspectroscopy as a triage test for cervical neoplasia: Pivotal clinical trial results

Leo B. Twiggs, Nahida Chakhtoura, Daron G. Ferris, Lisa C. Flowers, Marc L. Winter, Daniel R. Sternfeld, Manocher Lashgari, Alexander F. Burnett, Stephen S. Raab, Edward J. Wilkinson

Research output: Contribution to journalArticle

7 Scopus citations

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.

Original languageEnglish
Pages (from-to)147-151
Number of pages5
JournalGynecologic Oncology
Volume130
Issue number1
DOIs
StatePublished - Jul 1 2013

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Keywords

  • Cervical cancer detection
  • Sensitivity
  • Specificity
  • Spectroscopy

ASJC Scopus subject areas

  • Obstetrics and Gynecology
  • Oncology

Cite this

Twiggs, L. B., Chakhtoura, N., Ferris, D. G., Flowers, L. C., Winter, M. L., Sternfeld, D. R., Lashgari, M., Burnett, A. F., Raab, S. S., & Wilkinson, E. J. (2013). Multimodal hyperspectroscopy as a triage test for cervical neoplasia: Pivotal clinical trial results. Gynecologic Oncology, 130(1), 147-151. https://doi.org/10.1016/j.ygyno.2013.04.012