Cervical Cancer
Conditions
Brief 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.
Interventions
DRUGTMVP1-ICG
Detection of SLN
DRUGICG
Detection of SLN
Sponsors
Huazhong University of Science and Technology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Detection rate of sentinel lymph node | 1 day | Detection of sentinel lymph node per patient |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Specificity | 7 days | Specificity of SLN mapping of TMVP1-ICG compared to the sensitivity of SLN mapping of ICG |
| Incidence of adverse events | 7 days | — |
| Sensitivity | 7 days | Sensitivity of SLN mapping of TMVP1-ICG compared to the sensitivity of SLN mapping of ICG |
Countries
China
Contacts
Primary ContactDanhui Weng, Dr.
Outcome results
None listed