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TMTP1-ICG Mapping in Colposcopy-directed Biopsy

Sponsor
Huazhong University of Science and Technology (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT03321461
Collaborator
(none)
40
Enrollment
1
Location
2
Arms
49
Anticipated Duration (Months)
0.8
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Novel Tumor Targeted Fluorescent TMTP1-ICG Mapping in Colposcopy-directed Biopsy
Actual Study Start Date :
Nov 1, 2017
Actual Primary Completion Date :
Aug 31, 2020
Anticipated Study Completion Date :
Dec 1, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

Drug: TMTP1
Fluorescent sites will be removed
Active Comparator: 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.

Drug: ICG
Fluorescent sites will be removed

Outcome Measures

Primary Outcome Measures

  1. Sensitivity [1 day]

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

Secondary Outcome Measures

  1. Specificity [7 days]

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

  2. Incidence of adverse events [7 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 60 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Tongji Hospital, Tongji Medical Colledge, HUST Wuhan Hubei China 430030

Sponsors and Collaborators

  • Huazhong University of Science and Technology

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ding Ma, Director, Huazhong University of Science and Technology
ClinicalTrials.gov Identifier:
NCT03321461
Other Study ID Numbers:
  • TMTP1-ICG-02
First Posted:
Oct 25, 2017
Last Update Posted:
Jun 30, 2021
Last Verified:
Jun 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Cervical Intraepithelial Neoplasia

Study Results

No Results Posted as of Jun 30, 2021