TMTP1-ICG Mapping in Colposcopy-directed Biopsy

Huazhong University of Science and Technology

Status and phase: Unknown; Phase 1

Conditions: Cervical Intraepithelial Neoplasia

Treatments: Drug: ICG; Drug: TMTP1

Study type: Interventional

Funder types: Other

Identifiers

NCT03321461

TMTP1-ICG-02

Details and patient eligibility

About

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

Enrollment: 40 estimated patients

Sex: Female

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

TMTP1

Experimental group

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.

Treatment:

Drug: TMTP1

ICG

Active Comparator group

Description:

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.

Treatment:

Drug: ICG