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

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.