Fluorescence colposcope with dye TMTP1-PEG4-ICG is comparable to the
conventional colposcope with acetic acid and Lugol's iodine in
identifying cervical precancerous lesions - A randomized controlled
trial
Abstract
Objective: To compare the diagnostic efficiency of fluorescence
colposcope with dye TMTP1-PEG4-ICG versus conventional colposcope with
acetic acid and Lugol’s iodine in identifying cervical precancerous
lesions. Design and setting: Randomized controlled trial conducted at
Colposcopy Center. Population: Women with abnormal cervical cancer
screening results including cytology and/or HPV test. Methods: All
participants were randomized to fluorescence colposcope group or
conventional colposcope group. Patients of fluorescence colposcope group
were applied dye TMTP1-PEG4-ICG to the cervix uteri. Patients of
conventional colposcope group routinely administrated acetic acid and
Lugol’s iodine to stain the cervix uteri. Main outcome measures: The
colposcopists gave colposcope assessment impressions according to the
cervical staining reactions and fluorescence signal-to-background ratio
(SBR) calculation results. The diagnostic efficiency of fluorescence
colposcope and conventional colposcope was calculated on a per-patient
and per-site basis. Results: 195 women were successfully completed the
study protocol and were randomized to fluorescence colposcope group
(n=97) and conventional colposcope group (n=98). The accuracy,
sensitivity, specificity, positive predictive value (PPV) and negative
predictive value (NPV) of fluorescence colposcope on a per-patient basis
were 61.9%, 66.7%, 61.0%, 23.8%, 90.9%, respectively. The above
data corresponded to 73.9%, 69.6%, 74.2%, 15.5%, and 97.3% on a
per-site basis in fluorescence colposcope group. In the conventional
colposcope group, the above diagnostic indicators corresponded to
59.2%, 54.2%, 60.8%, 31.0%, 80.4%, respectively. Conclusions: The
fluorescence colposcope with dye TMTP1-PEG4-ICG was comparable to the
conventional colposcope with acetic acid and Lugol’s iodine, and
exhibited better accuracy, sensitivity and excellent NPV on the basis of
per cervical sites.