TMTP1-ICG Mapping in Colposcopy-directed Biopsy

Phase 1

• Conditions: Cervical Intraepithelial Neoplasia
• Interventions: Drug: TMTP1; Drug: ICG

• Registration Number: NCT03321461
• Lead Sponsor: Huazhong University of Science and Technology

Brief Summary

Investigators aimed to determine the validity of the novel tumor targeted fluorescent TMTP1-ICG to increased accuracy of colposcopy-directed biopsy.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-10-23
• Study First Submitted QC: 2017-10-23
• Study First Posted: 2017-10-25
• Study Start: 2017-11-01
• Primary Completion: 2020-08-31
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-26
• Last Update Posted: 2021-06-30
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TMTP1	TMTP1	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.
ICG	ICG	The ICG (WuXi AppTec, Shanghai, China) powder was diluted in 20 ml of aqueous sterile water to a concentration of 1.0 mg/mL. ICG spray was applied thoroughly to the ectocervix for 30 minutes. After cleaned by NS, fluorescent detected sites will be removed.

Primary Outcome Measures

Name	Time	Method
Sensitivity	1 day	Sensitivity of fluorescent detection of TMTP1-ICG compared to the sensitivity of ICG

Secondary Outcome Measures

Name	Time	Method
Specificity	7 days	Specificity of fluorescent detection of TMTP1-ICG compared to the sensitivity of ICG
Incidence of adverse events	7 days

Trial Locations

Locations (1)

Tongji Hospital, Tongji Medical Colledge, HUST; 🇨🇳 Wuhan, Hubei, China