TMTP1-ICG Mapping in Laparoscopic SLN Detection in Cervical Cancer
Novel Tumor Targeted Fluorescent TMTP1-ICG Mapping in Laparoscopic Sentinel Lymph Node Detection in Cervical Cancer Patients
1 other identifier
interventional
40
1 country
1
Brief Summary
investigators aimed to determine the validity of our novel tumor targeted fluorescent TMTP1-ICG to increased accuracy of laparoscopic SLN mapping
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Sep 2017
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2017
CompletedFirst Submitted
Initial submission to the registry
October 23, 2017
CompletedFirst Posted
Study publicly available on registry
October 25, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2019
CompletedOctober 27, 2017
October 1, 2017
1 year
October 23, 2017
October 25, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Detection rate of sentinel lymph node
Detection of sentinel lymph node per patient
1 day
Secondary Outcomes (3)
Sensitivity
7 days
Specificity
7 days
Incidence of adverse events
7 days
Study Arms (2)
TMTP1
EXPERIMENTALThe 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.
ICG
ACTIVE COMPARATORThe 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.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Tongji Hospital, Tongji Medical Colledge, HUST
Wuhan, Hubei, 430030, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director
Study Record Dates
First Submitted
October 23, 2017
First Posted
October 25, 2017
Study Start
September 1, 2017
Primary Completion
September 1, 2018
Study Completion
September 1, 2019
Last Updated
October 27, 2017
Record last verified: 2017-10