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 language | English |
|---|---|
| Pages (from-to) | 147-151 |
| Number of pages | 5 |
| Journal | Gynecologic Oncology |
| Volume | 130 |
| Issue number | 1 |
| DOIs | |
| State | Published - Jul 1 2013 |
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Keywords
- Cervical cancer detection
- Sensitivity
- Specificity
- Spectroscopy
ASJC Scopus subject areas
- Obstetrics and Gynecology
- Oncology
Cite this
Multimodal hyperspectroscopy as a triage test for cervical neoplasia : Pivotal clinical trial results. / Twiggs, Leo B.; Chakhtoura, Nahida; Ferris, Daron G.; 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 journal › Article
}
TY - JOUR
T1 - Multimodal hyperspectroscopy as a triage test for cervical neoplasia
T2 - Pivotal clinical trial results
AU - Twiggs, Leo B.
AU - Chakhtoura, Nahida
AU - Ferris, Daron G.
AU - Flowers, Lisa C.
AU - Winter, Marc L.
AU - Sternfeld, Daniel R.
AU - Lashgari, Manocher
AU - Burnett, Alexander F.
AU - Raab, Stephen S.
AU - Wilkinson, Edward J.
PY - 2013/7/1
Y1 - 2013/7/1
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.
KW - Cervical cancer detection
KW - Sensitivity
KW - Specificity
KW - Spectroscopy
UR - http://www.scopus.com/inward/record.url?scp=84879078014&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84879078014&partnerID=8YFLogxK
U2 - 10.1016/j.ygyno.2013.04.012
DO - 10.1016/j.ygyno.2013.04.012
M3 - Article
VL - 130
SP - 147
EP - 151
JO - Gynecologic Oncology
JF - Gynecologic Oncology
SN - 0090-8258
IS - 1
ER -