TMVP1-ICG Mapping in Laparoscopic SLN Detection in Cervical Cancer

Huazhong University of Science and Technology

Status and phase: Unknown; Phase 1

Conditions: Cervical Cancer

Treatments: Drug: ICG; Drug: TMVP1-ICG

Study type: Interventional

Funder types: Other

Identifiers

NCT03320772

TMVP1-ICG-01

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: Female

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

TMVP1

Experimental group

Description:

The TMVP1-ICG (WuXi AppTec, Shanghai, China) powder was diluted in 20 ml of aqueous sterile water to a concentration of 1.0 mg/mL. 0.4ml of TMVP1-ICG solution was injected into the cervix, divided into 3 and 9 o'clock position, in the operating room. During the laparoscopy, the PinPoint S1 Novadaq (PinPoint Endoscopic Fluorescence Imaging System, NOVADAQ, Mississauga, ON, Canada), 30° laparoscopes were used for fluorescent detection.

Treatment:

Drug: TMVP1-ICG

ICG

Active Comparator group

Description:

The ICG powder was diluted in 20 ml of aqueous sterile water to a concentration of 1.0 mg/mL. 0.4ml of this ICG solution was injected into the cervix, divided into 3 and 9 o'clock position, in the operating room. During the laparoscopy, the PinPoint S1 Novadaq (PinPoint Endoscopic Fluorescence Imaging System, NOVADAQ, Mississauga, ON, Canada), 30° laparoscopes were used for fluorescent detection.

Treatment:

Drug: ICG