TMTP1-ICG Mapping in Colposcopy-directed Biopsy

Huazhong University of Science and Technology40 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Cervical Intraepithelial Neoplasia

Interventions

TMTP1DRUG

Fluorescent sites will be removed

ICGDRUG

Fluorescent sites will be removed

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

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.

Locations (1)

Tongji Hospital, Tongji Medical Colledge, HUST

Wuhan, Hubei, China

Outcomes

Primary Outcomes

Sensitivity

Sensitivity of fluorescent detection of TMTP1-ICG compared to the sensitivity of ICG

Time frame: 1 day

Secondary Outcomes

Specificity

Specificity of fluorescent detection of TMTP1-ICG compared to the sensitivity of ICG

Time frame: 7 days

Incidence of adverse events

Time frame: 7 days

Data from ClinicalTrials.gov

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