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

Not Applicable

• Conditions: Breast Cancer; Sentinel Lymph Node
• Interventions: Procedure: Near infrared fluorescence navigated sentinel lymph node mapping

• Registration Number: NCT05365191
• Lead Sponsor: National Taiwan University Hospital Hsin-Chu Branch

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2022-04-08
• Study First Submitted: 2022-04-27
• Status Verified: 2022-05
• Study First Submitted QC: 2022-05-06
• Last Update Submitted: 2022-05-06
• Study First Posted: 2022-05-09
• Last Update Posted: 2022-05-09
• Primary Completion: 2023-04-07
• Study Completion: 2023-04-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Multispectral near infrared imaging	Near infrared fluorescence navigated sentinel lymph node mapping	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.

Primary Outcome Measures

Name	Time	Method
Signal-to-background ratio (SBR)	through study completion, an average of 1 year	Evaluates the SBR of the near-infrared fluorescence between the retrieved sentinel lymph nodes and the background.

Secondary Outcome Measures

Name	Time	Method
Sentinel lymph nodes pathology	through study completion, an average of 1 year	The positivity and number of retrieved sentinel lymph nodes at definitive pathology report.
Penetration depth	through study completion, an average of 1 year	Evaluates the depth of the deepest visualized subcutaneous lymphatics in the breast

Trial Locations

Locations (1)

National Taiwan University Hospital Hsin-Chu Branch Biomedical Park Hospital; 🇨🇳 Zhubei, HsinChu County, Taiwan