TMTP1-ICG Mapping in Laparoscopic SLN Detection in Cervical Cancer
Study Details
Study Description
Brief Summary
investigators aimed to determine the validity of our novel tumor targeted fluorescent TMTP1-ICG to increased accuracy of laparoscopic SLN mapping
Condition or Disease | Intervention/Treatment | Phase |
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Phase 1 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: TMTP1 The TMTP1-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 this TMTP1-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: TMTP1-ICG
Detection of SLN
|
Active Comparator: ICG The ICG powder was diluted in 20 ml of aqueous sterile water to a concentration of 1.0 mg/mL. 0.4ml of 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
Detection of SLN
|
Outcome Measures
Primary Outcome Measures
- Detection rate of sentinel lymph node [1 day]
Detection of sentinel lymph node per patient
Secondary Outcome Measures
- Sensitivity [7 days]
Sensitivity of SLN mapping of TMTP1-ICG compared to the sensitivity of SLN mapping of ICG
- Specificity [7 days]
Specificity of SLN mapping of TMTP1-ICG compared to the sensitivity of SLN mapping of ICG
- Incidence of adverse events [7 days]
Eligibility Criteria
Criteria
Inclusion Criteria:
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At least 18 years of age, married, without childbearing requirements at the time of consent.
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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.
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Subject has provided written informed consent.
Exclusion Criteria:
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Breast-feeding or pregnant
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Ongoing participation in another clinical trial with an investigational drug with 3 months
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Own allergy towards ICG and/or alcohol
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Diagnosis of bacterial vaginosis, fungal vaginitis, sexually transmitted diseases
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Patients with cardiac dysfunction or hepatic insufficiency or renal insufficiency
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Tongji Hospital, Tongji Medical Colledge, HUST | Wuhan | Hubei | China | 430030 |
Sponsors and Collaborators
- Huazhong University of Science and Technology
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- TMTP1-ICG-01