TMTP1 Targeting Micro-metastasis LN in Laparoscopic SLN Detection in Cervical Cancer
NCT ID: NCT03549195
Last Updated: 2018-06-07
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
NA
120 participants
INTERVENTIONAL
2018-06-01
2019-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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ICG
ICG
The ICG powder was diluted and injected into the cervix, divided into 3 and 9 o'clock position, 4 hours before surgery.
ICG-CP
CP, control peptide
ICG-CP
The ICG-CP powder was diluted and injected into the cervix, divided into 3 and 9 o'clock position, 4 hours before surgery.
ICG-TMTP1
also named as TMTP1-ICG
ICG-TMTP1
The ICG-TMTP1 powder was diluted and injected into the cervix, divided into 3 and 9 o'clock position, 4 hours before surgery.
Interventions
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ICG
The ICG powder was diluted and injected into the cervix, divided into 3 and 9 o'clock position, 4 hours before surgery.
ICG-CP
The ICG-CP powder was diluted and injected into the cervix, divided into 3 and 9 o'clock position, 4 hours before surgery.
ICG-TMTP1
The ICG-TMTP1 powder was diluted and injected into the cervix, divided into 3 and 9 o'clock position, 4 hours before surgery.
Eligibility Criteria
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Inclusion Criteria
* FIGO stage IB1, IIA1 cervical 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
30 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 College, HUST
Wuhan, Hubei, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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TMTP1-ICG-03
Identifier Type: -
Identifier Source: org_study_id
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