Spectroscopic imaging as a triage test for cervical disease: a prospective multicenter clinical trial.
OBJECTIVE
The objective of the study was to evaluate the potential safety and effectiveness of tissue spectroscopy for the diagnosis of cervical cancer in a prospective multicenter study of women scheduled for colposcopy on the basis of an abnormal Pap test or other risk factor.


METHODS
Five hundred seventy-two women underwent spectroscopy of the cervix during their colposcopy visit. Spectroscopy measurements taken over a scan period of 4 minutes and 30 seconds were integrated by a cross-validated pattern recognition model and compared with biopsy results to yield sensitivity and specificity of cervical spectroscopy.


RESULTS
The median age of subjects enrolled in the study was 27.7 years. The sensitivity of cervical spectroscopy was 95.1% with a corresponding 55.2% specificity for benign lesions. Several potential confounding factors (eg, mucous, blood, patient motion, ambient light) were examined to determine their potential impact on the accuracy of the test. Ambient light seemed to have the greatest effect, but no single factor contributed significantly to the results. The subjects did not experience any adverse events from undergoing the test.


CONCLUSIONS
Spectroscopy of the cervix has the potential to accurately detect cervical moderate and high-grade dysplasia while also reducing the false-positive rate for benign cervices. The test is relatively simple to implement and was well accepted by subjects enrolled in the study.
DeSantis
Timothy
T
University of Miami, Miami, FL, and St Francis Hospital-University of Connecticut, Hartford, CT, USA.
Chakhtoura
Nahida
N
Twiggs
Leo
L
Ferris
Daron
D
Lashgari
Manocher
M
Flowers
Lisa
L
Faupel
Mark
M
Bambot
Shabbir
S
Raab
Steven
S
Wilkinson
Edward
E
D000293:Adolescent; D000328:Adult; D000368:Aged; D000465:Algorithms; D005260:Female; D006801:Humans; D007090:Image Interpretation, Computer-Assisted; D008875:Middle Aged; D011446:Prospective Studies; D012680:Sensitivity and Specificity; D013050:Spectrometry, Fluorescence / Q000295:instrumentation; D002583:Uterine Cervical Neoplasms / Q000737:chemistry / Q000175:diagnosis*