TMTP1-ICG Mapping in Colposcopy-directed Biopsy
Novel Tumor Targeted Fluorescent TMTP1-ICG Mapping in Colposcopy-directed Biopsy
1 other identifier
interventional
40
1 country
1
Brief Summary
Investigators aimed to determine the validity of the novel tumor targeted fluorescent TMTP1-ICG to increased accuracy of colposcopy-directed biopsy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Nov 2017
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 23, 2017
CompletedFirst Posted
Study publicly available on registry
October 25, 2017
CompletedStudy Start
First participant enrolled
November 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2021
CompletedJune 30, 2021
June 1, 2021
2.8 years
October 23, 2017
June 26, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Sensitivity
Sensitivity of fluorescent detection of TMTP1-ICG compared to the sensitivity of ICG
1 day
Secondary Outcomes (2)
Specificity
7 days
Incidence of adverse events
7 days
Study Arms (2)
TMTP1
EXPERIMENTALThe 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
ACTIVE COMPARATORThe 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.
Interventions
Eligibility Criteria
You may qualify if:
- Suspicious of cervical disease required a colposcopy-directed biopsy.
- Subjects must sign an informed consent indicating awareness of the investigational nature of this study.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Tongji Hospital, Tongji Medical Colledge, HUST
Wuhan, Hubei, 430030, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director
Study Record Dates
First Submitted
October 23, 2017
First Posted
October 25, 2017
Study Start
November 1, 2017
Primary Completion
August 31, 2020
Study Completion
December 1, 2021
Last Updated
June 30, 2021
Record last verified: 2021-06