TMVP1-ICG Mapping in Laparoscopic SLN Detection in Cervical Cancer

Phase 1

• Conditions: Cervical Cancer
• Interventions: Drug: TMVP1-ICG; Drug: ICG

• Registration Number: NCT03320772
• Lead Sponsor: Huazhong University of Science and Technology

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-05-01
• Status Verified: 2017-10
• Study First Submitted: 2017-10-22
• Study First Submitted QC: 2017-10-24
• Last Update Submitted: 2017-10-24
• Study First Posted: 2017-10-25
• Last Update Posted: 2017-10-25
• Primary Completion: 2018-05
• Study Completion: 2019-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TMVP1	TMVP1-ICG	The TMVP1-ICG (WuXi AppTec, Shanghai, China) powder was diluted in 20 ml of aqueous sterile water to a concentration of 1.0 mg/mL. 0.4ml of TMVP1-ICG solution was injected into the cervix, divided into 3 and 9 o'clock position, in the operating room. During the laparoscopy, the PinPoint S1 Novadaq (PinPoint Endoscopic Fluorescence Imaging System, NOVADAQ, Mississauga, ON, Canada), 30° laparoscopes were used for fluorescent detection.
ICG	ICG	The ICG powder was diluted in 20 ml of aqueous sterile water to a concentration of 1.0 mg/mL. 0.4ml of this ICG solution was injected into the cervix, divided into 3 and 9 o'clock position, in the operating room. During the laparoscopy, the PinPoint S1 Novadaq (PinPoint Endoscopic Fluorescence Imaging System, NOVADAQ, Mississauga, ON, Canada), 30° laparoscopes were used for fluorescent detection.

Primary Outcome Measures

Name	Time	Method
Detection rate of sentinel lymph node	1 day	Detection of sentinel lymph node per patient

Secondary Outcome Measures

Name	Time	Method
Sensitivity	7 days	Sensitivity of SLN mapping of TMVP1-ICG compared to the sensitivity of SLN mapping of ICG
Specificity	7 days	Specificity of SLN mapping of TMVP1-ICG compared to the sensitivity of SLN mapping of ICG
Incidence of adverse events	7 days

Trial Locations

Locations (1)

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