TMVP1-ICG Mapping in Laparoscopic SLN Detection in Cervical Cancer

Phase 1UnknownNCT03320772

Huazhong University of Science and Technology40 enrolled

Overview

Sentinel lymph node (SLN) mapping is an acceptable surgical strategy determine whether to perform radical lymphadenectomy in patients with early-stage cervical cancer. Investigators aim to determine the validity of this technique with our novel tumor targeted fluorescent TMVP1-ICG to increased accuracy of SLN mapping.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Cervical Cancer

Interventions

TMVP1-ICGDRUG

Detection of SLN

ICGDRUG

Detection of SLN

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

Inclusion Criteria: * At least 18 years of age, married, without childbearing requirements at the time of consent. * FIGO stage IA1-IIB cervical squamous cell 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 Colledge, HUST

Wuhan, Hubei, China

RECRUITING

Outcomes

Primary Outcomes

Detection rate of sentinel lymph node

Detection of sentinel lymph node per patient

Time frame: 1 day

Secondary Outcomes

Sensitivity

Sensitivity of SLN mapping of TMVP1-ICG compared to the sensitivity of SLN mapping of ICG

Time frame: 7 days

Specificity

Specificity of SLN mapping of TMVP1-ICG compared to the sensitivity of SLN mapping of ICG

Time frame: 7 days

Incidence of adverse events

Time frame: 7 days

Central Contacts

Danhui Weng, Dr.

CONTACT

027-83663351 weng.dh@gmail.com

Data from ClinicalTrials.gov

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