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

Leo B. Twiggs, Nahida A. Chakhtoura, Daron Gale 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

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

Fingerprint

Triage
Papillomaviridae
Colposcopy
Clinical Trials
Referral and Consultation
Neoplasms
Biopsy
Cell Biology
Histology
Point-of-Care Systems
Uterine Cervical Dysplasia
Cervical Intraepithelial Neoplasia
Fluorescence Spectrometry
Early Detection of Cancer
Uterine Cervical Neoplasms
Equipment and Supplies
Population

Keywords

  • Cervical cancer detection
  • Sensitivity
  • Specificity
  • Spectroscopy

ASJC Scopus subject areas

  • Oncology
  • Obstetrics and Gynecology

Cite this

Twiggs, L. B., Chakhtoura, N. A., Ferris, D. G., Flowers, L. C., Winter, M. L., Sternfeld, D. R., ... 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

Multimodal hyperspectroscopy as a triage test for cervical neoplasia : Pivotal clinical trial results. / Twiggs, Leo B.; Chakhtoura, Nahida A.; Ferris, Daron Gale; Flowers, Lisa C.; Winter, Marc L.; Sternfeld, Daniel R.; Lashgari, Manocher; Burnett, Alexander F.; Raab, Stephen S.; Wilkinson, Edward J.

In: Gynecologic Oncology, Vol. 130, No. 1, 01.07.2013, p. 147-151.

Research output: Contribution to journalArticle

Twiggs, LB, Chakhtoura, NA, Ferris, DG, Flowers, LC, Winter, ML, Sternfeld, DR, Lashgari, M, Burnett, AF, Raab, SS & Wilkinson, EJ 2013, 'Multimodal hyperspectroscopy as a triage test for cervical neoplasia: Pivotal clinical trial results', Gynecologic Oncology, vol. 130, no. 1, pp. 147-151. https://doi.org/10.1016/j.ygyno.2013.04.012
Twiggs, Leo B. ; Chakhtoura, Nahida A. ; Ferris, Daron Gale ; Flowers, Lisa C. ; Winter, Marc L. ; Sternfeld, Daniel R. ; Lashgari, Manocher ; Burnett, Alexander F. ; Raab, Stephen S. ; Wilkinson, Edward J. / Multimodal hyperspectroscopy as a triage test for cervical neoplasia : Pivotal clinical trial results. In: Gynecologic Oncology. 2013 ; Vol. 130, No. 1. pp. 147-151.
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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.",
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AU - Winter, Marc L.

AU - Sternfeld, Daniel R.

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AU - Raab, Stephen S.

AU - Wilkinson, Edward J.

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N2 - 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.

AB - 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.

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