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

Huazhong University of Science and Technology120 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

120

Conditions

Cervical Cancer Sentinel Lymph Node

Interventions

ICGPROCEDURE

The ICG powder was diluted and injected into the cervix, divided into 3 and 9 o'clock position, 4 hours before surgery.

ICG-CPPROCEDURE

The ICG-CP powder was diluted and injected into the cervix, divided into 3 and 9 o'clock position, 4 hours before surgery.

ICG-TMTP1PROCEDURE

The ICG-TMTP1 powder was diluted and injected into the cervix, divided into 3 and 9 o'clock position, 4 hours before surgery.

Eligibility

Sex: FEMALEMin age: 30 YearsMax age: 60 Years

Medical Language ↔ Plain English

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

Locations (1)

Tongji Hospital, Tongji Medical College, HUST

Wuhan, Hubei, China

Outcomes

Primary Outcomes

Detection rate of micro-metastasis sentinel lymph node

Detection of micro-metastasis sentinel lymph node per patient

Time frame: 7 days

Secondary Outcomes

Sensitivity

Sensitivity of SLN mapping of TMTP1-ICG compared to the sensitivity of SLN mapping of ICG or ICG-CP

Time frame: 7 days

Specificity

Specificity of SLN mapping of TMTP1-ICG compared to the sensitivity of SLN mapping of ICG or ICG-CP

Time frame: 7 days

Incidence of adverse events

Time frame: 7 days

Central Contacts

Danhui H Weng, MD

CONTACT

02783663351 weng.dh@gmail.com

Data from ClinicalTrials.gov

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