TMTP1 Targeting Micro-metastasis LN in Laparoscopic SLN Detection in Cervical Cancer

June 6, 2018 updated by: Ding Ma, Huazhong University of Science and Technology

Novel Tumor Targeted Fluorescent Peptide TMTP1-ICG Mapping in Laparoscopic Sentinel Micro-metastasis Lymph Node Detection in Cervical Cancer Patients

Investigators aimed to determine the validity of the investigator's novel tumor targeted fluorescent peptide TMTP1-ICG to increased accuracy of laparoscopic SLN mapping

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Hubei
      • Wuhan, Hubei, China, 430030
        • Tongji Hospital, Tongji Medical College, HUST

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: ICG
Procedure: ICG
The ICG powder was diluted and injected into the cervix, divided into 3 and 9 o'clock position, 4 hours before surgery.
ACTIVE_COMPARATOR: ICG-CP
CP, control peptide
Procedure: 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.
EXPERIMENTAL: ICG-TMTP1
also named as TMTP1-ICG
Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Detection rate of micro-metastasis sentinel lymph node
Time Frame: 7 days
Detection of micro-metastasis sentinel lymph node per patient
7 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensitivity
Time Frame: 7 days
Sensitivity of SLN mapping of TMTP1-ICG compared to the sensitivity of SLN mapping of ICG or ICG-CP
7 days
Specificity
Time Frame: 7 days
Specificity of SLN mapping of TMTP1-ICG compared to the sensitivity of SLN mapping of ICG or ICG-CP
7 days
Incidence of adverse events
Time Frame: 7 days
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Huazhong University of Science and Technology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

June 1, 2018

Primary Completion (ANTICIPATED)

June 1, 2019

Study Completion (ANTICIPATED)

December 31, 2019

Study Registration Dates

First Submitted

May 25, 2018

First Submitted That Met QC Criteria

June 6, 2018

First Posted (ACTUAL)

June 7, 2018

Study Record Updates

Last Update Posted (ACTUAL)

June 7, 2018

Last Update Submitted That Met QC Criteria

June 6, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TMTP1-ICG-03

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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