TMVP1-ICG Mapping in Laparoscopic SLN Detection in Cervical Cancer

• Status: Unknown status
• Trial end date: 2019-05-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Huazhong University of Science and Technology

Criteria

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