TMTP1-ICG Mapping in Laparoscopic SLN Detection in Cervical Cancer
NCT ID: NCT03321448
Last Updated: 2017-10-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
40 participants
INTERVENTIONAL
2017-09-01
2019-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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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.
TMTP1-ICG
Detection of SLN
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.
ICG
Detection of SLN
Interventions
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TMTP1-ICG
Detection of SLN
ICG
Detection of SLN
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
60 Years
FEMALE
No
Sponsors
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Huazhong University of Science and Technology
OTHER
Responsible Party
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Ding Ma
Director
Locations
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Tongji Hospital, Tongji Medical Colledge, HUST
Wuhan, Hubei, China
Countries
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Central Contacts
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Facility Contacts
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Juncheng Wei, Dr.
Role: primary
Other Identifiers
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TMTP1-ICG-01
Identifier Type: -
Identifier Source: org_study_id