Cervical Intraepithelial Neoplasia
Conditions
Brief summary
Investigators aimed to determine the validity of the novel tumor targeted fluorescent TMTP1-ICG to increased accuracy of colposcopy-directed biopsy.
Interventions
DRUGTMTP1
Fluorescent sites will be removed
DRUGICG
Fluorescent sites will be removed
Sponsors
Huazhong University of Science and Technology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Suspicious of cervical disease required a colposcopy-directed biopsy. * Subjects must sign an informed consent indicating awareness of the investigational nature of this study.
Exclusion criteria
* Breast-feeding or pregnant. * Ongoing participation in another clinical trial with an investigational drug with 3 months. * Own allergy towards ICG and/or alcohol. * Diagnosis of bacterial vaginosis, fungal vaginitis, sexually transmitted diseases. * Patients with cardiac dysfunction or hepatic insufficiency or renal insufficiency.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity | 1 day | Sensitivity of fluorescent detection of TMTP1-ICG compared to the sensitivity of ICG |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Specificity | 7 days | Specificity of fluorescent detection of TMTP1-ICG compared to the sensitivity of ICG |
| Incidence of adverse events | 7 days | — |
Countries
China
Outcome results
None listed