TMTP1 Targeting Micro-metastasis LN in Laparoscopic SLN Detection in Cervical Cancer
Novel Tumor Targeted Fluorescent Peptide TMTP1-ICG Mapping in Laparoscopic Sentinel Micro-metastasis Lymph Node Detection in Cervical Cancer Patients
1 other identifier
interventional
120
1 country
1
Brief Summary
Investigators aimed to determine the validity of the investigator's novel tumor targeted fluorescent peptide 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 not_applicable
Started Jun 2018
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
First Submitted
Initial submission to the registry
May 25, 2018
CompletedStudy Start
First participant enrolled
June 1, 2018
CompletedFirst Posted
Study publicly available on registry
June 7, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2019
CompletedJune 7, 2018
May 1, 2018
1 year
May 25, 2018
June 6, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Detection rate of micro-metastasis sentinel lymph node
Detection of micro-metastasis sentinel lymph node per patient
7 days
Secondary Outcomes (3)
Sensitivity
7 days
Specificity
7 days
Incidence of adverse events
7 days
Study Arms (3)
ICG
ACTIVE COMPARATORICG-CP
ACTIVE COMPARATORCP, control peptide
ICG-TMTP1
EXPERIMENTALalso named as TMTP1-ICG
Interventions
The ICG powder was diluted and injected into the cervix, divided into 3 and 9 o'clock position, 4 hours before surgery.
The ICG-CP powder was diluted and injected into the cervix, divided into 3 and 9 o'clock position, 4 hours before surgery.
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
You may qualify if:
- Without childbearing requirements at the time of consent.
- 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.
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 College, HUST
Wuhan, Hubei, 430030, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director
Study Record Dates
First Submitted
May 25, 2018
First Posted
June 7, 2018
Study Start
June 1, 2018
Primary Completion
June 1, 2019
Study Completion
December 31, 2019
Last Updated
June 7, 2018
Record last verified: 2018-05
Data Sharing
- IPD Sharing
- Will not share