Brief Title
TMTP1-ICG Mapping in Colposcopy-directed Biopsy
Official Title
Novel Tumor Targeted Fluorescent TMTP1-ICG Mapping in Colposcopy-directed Biopsy
Brief Summary
Investigators aimed to determine the validity of the novel tumor targeted fluorescent TMTP1-ICG to increased accuracy of colposcopy-directed biopsy.
Study Phase
Phase 1
Study Type
Interventional
Primary Outcome
Sensitivity
Secondary Outcome
Specificity
Condition
Cervical Intraepithelial Neoplasia
Intervention
TMTP1
Study Arms / Comparison Groups
TMTP1
Description: The TMTP1-ICG (WuXi AppTec, Shanghai, China) powder was diluted in 20 ml of aqueous sterile water to a concentration of 1.0 mg/mL. Then TMTP1-ICG spray was applied thoroughly to the ectocervix for 30 minutes. After cleaned by NS, fluorescent detected sites will be removed.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
40
Start Date
November 1, 2017
Completion Date
September 2019
Primary Completion Date
September 2018
Eligibility Criteria
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.
Gender
Female
Ages
18 Years - 60 Years
Accepts Healthy Volunteers
No
Contacts
, 027-83663351, [email protected]
Location Countries
China
Location Countries
China
Administrative Informations
NCT ID
NCT03321461
Organization ID
TMTP1-ICG-02
Responsible Party
Principal Investigator
Study Sponsor
Huazhong University of Science and Technology
Study Sponsor
, ,
Verification Date
October 2017