Back to resultsTMTP1 Targeting Micro-metastasis LN in Laparoscopic SLN Detection in Cervical Cancer
Primary Purpose
Cervical Cancer, Sentinel Lymph Node
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
ICG
ICG-CP
ICG-TMTP1
Sponsored by
About this trial
This is an interventional treatment trial for Cervical Cancer
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Sites / Locations
- Tongji Hospital, Tongji Medical College, HUST
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Experimental
Arm Label
ICG
ICG-CP
ICG-TMTP1
Arm Description
CP, control peptide
also named as TMTP1-ICG
Outcomes
Primary Outcome Measures
Detection rate of micro-metastasis sentinel lymph node
Detection of micro-metastasis sentinel lymph node per patient
Secondary Outcome Measures
Sensitivity
Sensitivity of SLN mapping of TMTP1-ICG compared to the sensitivity of SLN mapping of ICG or ICG-CP
Specificity
Specificity of SLN mapping of TMTP1-ICG compared to the sensitivity of SLN mapping of ICG or ICG-CP
Incidence of adverse events
Full Information
NCT ID
NCT03549195
First Posted
May 25, 2018
Last Updated
June 6, 2018
Sponsor
Huazhong University of Science and Technology
1. Study Identification
Unique Protocol Identification Number
NCT03549195
Brief Title
TMTP1 Targeting Micro-metastasis LN in Laparoscopic SLN Detection in Cervical Cancer
Official Title
Novel Tumor Targeted Fluorescent Peptide TMTP1-ICG Mapping in Laparoscopic Sentinel Micro-metastasis Lymph Node Detection in Cervical Cancer Patients
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Unknown status
Study Start Date
June 1, 2018 (Anticipated)
Primary Completion Date
June 1, 2019 (Anticipated)
Study Completion Date
December 31, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Huazhong University of Science and Technology
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Cancer, Sentinel Lymph Node
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ICG
Arm Type
Active Comparator
Arm Title
ICG-CP
Arm Type
Active Comparator
Arm Description
CP, control peptide
Arm Title
ICG-TMTP1
Arm Type
Experimental
Arm Description
also named as TMTP1-ICG
Intervention Type
Procedure
Intervention Name(s)
ICG
Intervention Description
The ICG powder was diluted and injected into the cervix, divided into 3 and 9 o'clock position, 4 hours before surgery.
Intervention Type
Procedure
Intervention Name(s)
ICG-CP
Intervention Description
The ICG-CP powder was diluted and injected into the cervix, divided into 3 and 9 o'clock position, 4 hours before surgery.
Intervention Type
Procedure
Intervention Name(s)
ICG-TMTP1
Intervention Description
The ICG-TMTP1 powder was diluted and injected into the cervix, divided into 3 and 9 o'clock position, 4 hours before surgery.
Primary Outcome Measure Information:
Title
Detection rate of micro-metastasis sentinel lymph node
Description
Detection of micro-metastasis sentinel lymph node per patient
Time Frame
7 days
Secondary Outcome Measure Information:
Title
Sensitivity
Description
Sensitivity of SLN mapping of TMTP1-ICG compared to the sensitivity of SLN mapping of ICG or ICG-CP
Time Frame
7 days
Title
Specificity
Description
Specificity of SLN mapping of TMTP1-ICG compared to the sensitivity of SLN mapping of ICG or ICG-CP
Time Frame
7 days
Title
Incidence of adverse events
Time Frame
7 days
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Danhui H Weng, MD
Phone
02783663351
Email
weng.dh@gmail.com
Facility Information:
Facility Name
Tongji Hospital, Tongji Medical College, HUST
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430030
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Danhui Weng, MD
Phone
02783663351
Ext
02783663351
Email
weng.dh@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
TMTP1 Targeting Micro-metastasis LN in Laparoscopic SLN Detection in Cervical Cancer
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