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

Cervical Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03549195
• Other study ID #: TMTP1-ICG-03
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2018
• Est. completion date: December 31, 2019

Study information

• Verified date: May 2018
• Source: Huazhong University of Science and Technology
• Contact: Danhui H Weng, MD
• Phone: 02783663351
• Email: weng.dh[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: December 31, 2019
• Est. primary completion date: June 1, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 30 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Cervical Cancer
• Sentinel Lymph Node
• Uterine Cervical Neoplasms

Intervention

Procedure:
• ICG
The ICG powder was diluted and injected into the cervix, divided into 3 and 9 o'clock position, 4 hours before surgery.
• 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.
• 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.

Locations

Country	Name	City	State
China	Tongji Hospital, Tongji Medical College, HUST	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Huazhong University of Science and Technology

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Detection rate of micro-metastasis sentinel lymph node	Detection of micro-metastasis sentinel lymph node per patient	7 days
Secondary	Sensitivity	Sensitivity of SLN mapping of TMTP1-ICG compared to the sensitivity of SLN mapping of ICG or ICG-CP	7 days
Secondary	Specificity	Specificity of SLN mapping of TMTP1-ICG compared to the sensitivity of SLN mapping of ICG or ICG-CP	7 days
Secondary	Incidence of adverse events		7 days