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NCT03320772 Clinical Trial

TMVP1-ICG Mapping in Laparoscopic SLN Detection in Cervical Cancer

Cervical Cancer Clinical Trial

Official title:
Novel Tumor Targeted Fluorescent TMTP1-ICG Mapping in Laparoscopic Sentinel Lymph Node Detection in Cervical Cancer Patients

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03320772
Other study ID # TMVP1-ICG-01
Secondary ID
Status Recruiting
Phase Phase 1
First received October 22, 2017
Last updated October 24, 2017
Start date May 1, 2017
Est. completion date May 2019

Study information
Verified date October 2017
Source Huazhong University of Science and Technology
Contact Danhui Weng, Dr.
Phone 027-83663351
Email weng.dh@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Sentinel lymph node (SLN) mapping is an acceptable surgical strategy determine whether to perform radical lymphadenectomy in patients with early-stage cervical cancer. Investigators aim to determine the validity of this technique with our novel tumor targeted fluorescent TMVP1-ICG to increased accuracy of SLN mapping.

Recruitment information / eligibility
Status Recruiting
Enrollment 40
Est. completion date May 2019
Est. primary completion date May 2018
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria:

- At least 18 years of age, married, without childbearing requirements at the time of consent.

- FIGO stage IA1-IIB cervical squamous cell 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• TMVP1-ICG
Detection of SLN
• ICG
Detection of SLN

Locations
Country Name City State
China Tongji Hospital, Tongji Medical Colledge, 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 sentinel lymph node Detection of sentinel lymph node per patient 1 day
Secondary Sensitivity Sensitivity of SLN mapping of TMVP1-ICG compared to the sensitivity of SLN mapping of ICG 7 days
Secondary Specificity Specificity of SLN mapping of TMVP1-ICG compared to the sensitivity of SLN mapping of ICG 7 days
Secondary Incidence of adverse events 7 days
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