TMVP1-ICG Mapping in Laparoscopic SLN Detection in Cervical Cancer

Study Overview
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Brief Summary
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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.

Official Title
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Novel Tumor Targeted Fluorescent TMTP1-ICG Mapping in Laparoscopic Sentinel Lymph Node Detection in Cervical Cancer Patients

Conditions
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Cervical Cancer

Intervention / Treatment
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* Drug: TMVP1-ICG
* Drug: ICG


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TMVP1<br>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. | Drug: TMVP1-ICG<br>* Detection of SLN<br>|
| Active Comparator: ICG<br>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. | Drug: ICG<br>* Detection of SLN<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Detection rate of sentinel lymph node | Detection of sentinel lymph node per patient | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity | Sensitivity of SLN mapping of TMVP1-ICG compared to the sensitivity of SLN mapping of ICG | 7 days | 
| Specificity | Specificity of SLN mapping of TMVP1-ICG compared to the sensitivity of SLN mapping of ICG | 7 days | 
| Incidence of adverse events |  | 7 days |