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
Ying Zhoua*, Chen Wangb*, Wei Lia*, Wanrong Lu a, Xiaohu Liub, Ling Xia, Pengcheng Lib,c, Jinling Lub, Juncheng Weia
a Department of Obstetrics and Gynecology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China
b Britton Chance Center and MoE Key Laboratory for Biomedical Photonics, Wuhan National Laboratory for Optoelectronics, Huazhong University of Science and Technology, Wuhan, China
c Research Unit of Multimodal Cross Scale Neural Signal Detection and Imaging, Chinese Academy of Medical Sciences, 2019RU002; HUST-Suzhou Institute for Brainsmatics, JITRI, Suzhou, China
* These authors contributed equally to this work
Correspondence: Juncheng Wei, Ph.D., Department of Obstetrics and Gynecology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 430030, China. Email: wjcwjc999@126.com.
Jinling Lu, Ph.D., Britton Chance Center for Biomedical Photonics, Wuhan National Laboratory for Optoelectronics-Huazhong University of Science and Technology, Wuhan, 430074, China. Email: lujinling@mail.hust.edu.cn.
Running Title: Fluorescence colposcope identify cervical lesions.
­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.
Keywords: Fluorescence colposcope; Cervical cancer screening; Cervical intraepithelial neoplasia; Diagnostic imaging; TMTP1-PEG4-ICG