Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03549195
Recruitment Status : Not yet recruiting
First Posted : June 7, 2018
Last Update Posted : June 7, 2018
Sponsor:
Information provided by (Responsible Party):
Ding Ma, Huazhong University of Science and Technology

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

Condition or disease Intervention/treatment Phase
Cervical Cancer Sentinel Lymph Node Procedure: ICG Procedure: ICG-CP Procedure: ICG-TMTP1 Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Novel Tumor Targeted Fluorescent Peptide TMTP1-ICG Mapping in Laparoscopic Sentinel Micro-metastasis Lymph Node Detection in Cervical Cancer Patients
Estimated Study Start Date : June 1, 2018
Estimated Primary Completion Date : June 1, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cervical Cancer

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.




Primary Outcome Measures :
  1. Detection rate of micro-metastasis sentinel lymph node [ Time Frame: 7 days ]
    Detection of micro-metastasis sentinel lymph node per patient


Secondary Outcome Measures :
  1. Sensitivity [ Time Frame: 7 days ]
    Sensitivity of SLN mapping of TMTP1-ICG compared to the sensitivity of SLN mapping of ICG or ICG-CP

  2. Specificity [ Time Frame: 7 days ]
    Specificity of SLN mapping of TMTP1-ICG compared to the sensitivity of SLN mapping of ICG or ICG-CP

  3. Incidence of adverse events [ Time Frame: 7 days ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   30 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03549195


Contacts
Layout table for location contacts
Contact: Danhui H Weng, MD 02783663351 weng.dh@gmail.com

Locations
Layout table for location information
China, Hubei
Tongji Hospital, Tongji Medical College, HUST Not yet recruiting
Wuhan, Hubei, China, 430030
Contact: Danhui Weng, MD    02783663351 ext 02783663351    weng.dh@gmail.com   
Sponsors and Collaborators
Huazhong University of Science and Technology

Layout table for additonal information
Responsible Party: Ding Ma, Director, Huazhong University of Science and Technology
ClinicalTrials.gov Identifier: NCT03549195     History of Changes
Other Study ID Numbers: TMTP1-ICG-03
First Posted: June 7, 2018    Key Record Dates
Last Update Posted: June 7, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Uterine Cervical Neoplasms
Neoplasm Micrometastasis
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Neoplasm Metastasis
Neoplastic Processes
Pathologic Processes