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

Huazhong University of Science and Technology

Status: Unknown

Conditions: Sentinel Lymph Node; Cervical Cancer

Treatments: Procedure: ICG-TMTP1; Procedure: ICG; Procedure: ICG-CP

Study type: Interventional

Funder types: Other

Identifiers

NCT03549195

TMTP1-ICG-03

Details and patient eligibility

About

Investigators aimed to determine the validity of the investigator's novel tumor targeted fluorescent peptide TMTP1-ICG to increased accuracy of laparoscopic SLN mapping

Enrollment: 120 estimated patients

Sex: Female

Ages: 30 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 3 patient groups

ICG

Active Comparator group

Treatment:

Procedure: ICG

ICG-CP

Active Comparator group

Description:

CP, control peptide

Treatment:

Procedure: ICG-CP

ICG-TMTP1

Experimental group

Description:

also named as TMTP1-ICG

Treatment:

Procedure: ICG-TMTP1