TMTP1-ICG Mapping in Colposcopy-directed Biopsy

NCT ID: NCT03321461

Last Updated: 2021-06-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-01

Study Completion Date

2021-12-31

Brief Summary

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

Detailed Description

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Conditions

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Cervical Intraepithelial Neoplasia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

TMTP1

Intervention Type DRUG

Fluorescent sites will be removed

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.

Group Type ACTIVE_COMPARATOR

ICG

Intervention Type DRUG

Fluorescent sites will be removed

Interventions

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TMTP1

Fluorescent sites will be removed

Intervention Type DRUG

ICG

Fluorescent sites will be removed

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Huazhong University of Science and Technology

OTHER

Sponsor Role lead

Responsible Party

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Ding Ma

Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Tongji Hospital, Tongji Medical Colledge, HUST

Wuhan, Hubei, China

Site Status

Countries

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China

Other Identifiers

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TMTP1-ICG-02

Identifier Type: -

Identifier Source: org_study_id

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