A Study Evaluating Near-infrared Zone II Imaging in Sentinel Lymph Node Mapping in Breast Cancer Patients

National Taiwan University Hospital Hsin-Chu Branch

Status: Enrolling

Conditions: Sentinel Lymph Node; Breast Cancer

Treatments: Procedure: Near infrared fluorescence navigated sentinel lymph node mapping

Study type: Interventional

Funder types: Other

Identifiers

NCT05365191

110-163-F

Details and patient eligibility

About

This study aims for evaluating near infrared zone II imaging in sentinel lymph node mapping in breast cancer patients.

Full description

Multi-wavelength fluorescence has been surveyed in various fields of surgery. However, it was still under investigation, and has not been matured for clinical use. This study will evaluate near infrared zone II spectrums for breast cancer patient undergoing sentinel lymph node mapping with near-infrared fluorescence navigation.

Enrollment: 30 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Breast cancer, adults

Exclusion criteria

• Patient aged < 20 years old
• Primary lesion without indication of sentinel lymph node biopsy in current guidelines (Low-risk ductal carcinoma in situ or metastatic breast cancer)
• Patient who is allergic to primary tracers (including Tc99m and blue dye)
• Patient who is allergic to indocyanine green

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Multispectral near infrared imaging

Other group

Description:

The participants will be assigned to one single arm that accepted both near infrared zone I and near infrared zone II imaging during the near infrared fluorescence navigated sentinel lymph node biopsy procedure. Imaging quality will be compared between different spectrums.

Treatment:

Procedure: Near infrared fluorescence navigated sentinel lymph node mapping