Status:
UNKNOWN
TMTP1-ICG Mapping in Colposcopy-directed Biopsy
Lead Sponsor:
Huazhong University of Science and Technology
Conditions:
Cervical Intraepithelial Neoplasia
Eligibility:
FEMALE
18-60 years
Phase:
PHASE1
Brief Summary
Investigators aimed to determine the validity of the novel tumor targeted fluorescent TMTP1-ICG to increased accuracy of colposcopy-directed biopsy.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2021
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT03321461
Start Date
November 1 2017
End Date
December 1 2021
Last Update
June 30 2021
Active Locations (1)
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1
Tongji Hospital, Tongji Medical Colledge, HUST
Wuhan, Hubei, China, 430030