Patient characteristics
Between 4 December 2018 and 13 August 2020, a total of 218 women were enrolled and 195 women were finally analyzed in this study (Figure 1). The trial ended when the sample size requirement was reached. 18 women withdrew from the study based on their own willingness, and 5 women with vaginal lesions were not included in the final statistical analysis. 97 women underwent fluorescence colposcope guided biopsy with NIR fluorescent dye TMTP1-PEG4-ICG, and another 98 underwent conventional colposcope directed biopsies with acetic acid and Lugol’s iodine solution. As shown in Table 1, the average age of the fluorescence group and the conventional group was 41.7 and 39.9, respectively. In the fluorescence group, 35 patients had an abnormal Thinprep cytologic test (TCT) and 91 had a positive HPV test. For the conventional group, there were 27 and 94 patients with abnormal TCT and HPV positive, respectively.
Comparison of imaging characteristics betweenfluorescencecolposcope and conventional colposcopy
Typical images captured with the colposcope were shown in Figure 2. Fluorescence colposcope could show specific fluorescence signals at cervical lesions in patients with CIN 3 (from patient of No.15), and the patient with normal pathological result (from patient of No.68) had no obvious fluorescence signal at the cervix. Representative visible light pictures, fluorescent pictures and combined pictures were displayed in Figure 2A. As for conventional colposcopy, acetic acid stained the cervical lesions of CIN 2-3 patient (from patient of No.16) white, while Lugol’s iodine didn’t stain the lesion. And patient with benign cervix (from patient of No.38) had no acetic acid white reaction and normal iodine intake. The representative original pictures, acetic acid staining pictures and iodine staining pictures of the conventional colposcopy group were displayed in Figure 2B. Both groups of patients had no obvious local irritation during cervical staining and colposcopy.