TMTP1 Targeting Micro-metastasis LN in Laparoscopic SLN Detection in Cervical Cancer

Not Applicable

• Conditions: Cervical Cancer; Sentinel Lymph Node
• Interventions: Procedure: ICG-CP; Procedure: ICG-TMTP1; Procedure: ICG

• Registration Number: NCT03549195
• Lead Sponsor: Huazhong University of Science and Technology

Brief Summary

Investigators aimed to determine the validity of the investigator's novel tumor targeted fluorescent peptide TMTP1-ICG to increased accuracy of laparoscopic SLN mapping

Detailed Description

Not available

Study Timeline

• Status Verified: 2018-05
• Study First Submitted: 2018-05-25
• Study Start: 2018-06-01
• Study First Submitted QC: 2018-06-06
• Last Update Submitted: 2018-06-06
• Study First Posted: 2018-06-07
• Last Update Posted: 2018-06-07
• Primary Completion: 2019-06-01
• Study Completion: 2019-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 120

Inclusion Criteria

• Without childbearing requirements at the time of consent.
• FIGO stage IB1, IIA1 cervical cancer and is a candidate for laparoscopy intervention, with lymph node dissection being a part of the surgical plan.
• Subject has provided written informed consent.

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ICG-CP	ICG-CP	CP, control peptide
ICG-TMTP1	ICG-TMTP1	also named as TMTP1-ICG
ICG	ICG	-

Primary Outcome Measures

Name	Time	Method
Detection rate of micro-metastasis sentinel lymph node	7 days	Detection of micro-metastasis sentinel lymph node per patient

Secondary Outcome Measures

Name	Time	Method
Sensitivity	7 days	Sensitivity of SLN mapping of TMTP1-ICG compared to the sensitivity of SLN mapping of ICG or ICG-CP
Incidence of adverse events	7 days
Specificity	7 days	Specificity of SLN mapping of TMTP1-ICG compared to the sensitivity of SLN mapping of ICG or ICG-CP

Trial Locations

Locations (1)

Tongji Hospital, Tongji Medical College, HUST; 🇨🇳 Wuhan, Hubei, China