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