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NCT03321461 Clinical Trial

TMTP1-ICG Mapping in Colposcopy-directed Biopsy

Cervical Intraepithelial Neoplasia Clinical Trial

Official title:
Novel Tumor Targeted Fluorescent TMTP1-ICG Mapping in Colposcopy-directed Biopsy

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT03321461
Other study ID # TMTP1-ICG-02
Secondary ID
Status Active, not recruiting
Phase Phase 1
First received
Last updated
Start date November 1, 2017
Est. completion date December 2021

Study information
Verified date June 2021
Source Huazhong University of Science and Technology
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 40
Est. completion date December 2021
Est. primary completion date August 31, 2020
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 60 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• TMTP1
Fluorescent sites will be removed
• ICG
Fluorescent sites will be removed

Locations
Country Name City State
China Tongji Hospital, Tongji Medical Colledge, HUST Wuhan Hubei

Sponsors (1)
Lead Sponsor Collaborator
Huazhong University of Science and Technology

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Sensitivity Sensitivity of fluorescent detection of TMTP1-ICG compared to the sensitivity of ICG 1 day
Secondary Specificity Specificity of fluorescent detection of TMTP1-ICG compared to the sensitivity of ICG 7 days
Secondary Incidence of adverse events 7 days
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