Back to resultsTMTP1-ICG Mapping in Colposcopy-directed Biopsy
Primary Purpose
Cervical Intraepithelial Neoplasia
Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
TMTP1
ICG
Sponsored by
About this trial
This is an interventional diagnostic trial for Cervical Intraepithelial Neoplasia
Eligibility Criteria
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.
Sites / Locations
- Tongji Hospital, Tongji Medical Colledge, HUST
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
TMTP1
ICG
Arm 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.
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.
Outcomes
Primary Outcome Measures
Sensitivity
Sensitivity of fluorescent detection of TMTP1-ICG compared to the sensitivity of ICG
Secondary Outcome Measures
Specificity
Specificity of fluorescent detection of TMTP1-ICG compared to the sensitivity of ICG
Incidence of adverse events
Full Information
NCT ID
NCT03321461
First Posted
October 23, 2017
Last Updated
June 26, 2021
Sponsor
Huazhong University of Science and Technology
1. Study Identification
Unique Protocol Identification Number
NCT03321461
Brief Title
TMTP1-ICG Mapping in Colposcopy-directed Biopsy
Official Title
Novel Tumor Targeted Fluorescent TMTP1-ICG Mapping in Colposcopy-directed Biopsy
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Unknown status
Study Start Date
November 1, 2017 (Actual)
Primary Completion Date
August 31, 2020 (Actual)
Study Completion Date
December 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Huazhong University of Science and Technology
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Investigators aimed to determine the validity of the novel tumor targeted fluorescent TMTP1-ICG to increased accuracy of colposcopy-directed biopsy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Intraepithelial Neoplasia
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
TMTP1
Arm Type
Experimental
Arm 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.
Arm Title
ICG
Arm Type
Active Comparator
Arm 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.
Intervention Type
Drug
Intervention Name(s)
TMTP1
Intervention Description
Fluorescent sites will be removed
Intervention Type
Drug
Intervention Name(s)
ICG
Intervention Description
Fluorescent sites will be removed
Primary Outcome Measure Information:
Title
Sensitivity
Description
Sensitivity of fluorescent detection of TMTP1-ICG compared to the sensitivity of ICG
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Specificity
Description
Specificity of fluorescent detection of TMTP1-ICG compared to the sensitivity of ICG
Time Frame
7 days
Title
Incidence of adverse events
Time Frame
7 days
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Tongji Hospital, Tongji Medical Colledge, HUST
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430030
Country
China
12. IPD Sharing Statement
Learn more about this trial
TMTP1-ICG Mapping in Colposcopy-directed Biopsy
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