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

Overview

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

Full Title of Study: “Development and Utilization of Indocyanine Green Fluorescence Near Infrared Zone II Lymphography in Breast Cancer Patients”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Basic Science
    • Masking: None (Open Label)
  • Study Primary Completion Date: April 7, 2023

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.

Interventions

  • Procedure: Near infrared fluorescence navigated sentinel lymph node mapping
    • Participants undergo sentinel lymph node biopsy for breast cancer, and use blue dye/Tc99m radioisotope as primary tracer. Indocyanine green near infrared fluorescence as secondary tracer for mapping.

Arms, Groups and Cohorts

  • Other: Multispectral near infrared imaging
    • 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.

Clinical Trial Outcome Measures

Primary Measures

  • Signal-to-background ratio (SBR)
    • Time Frame: 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 Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 20 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • National Taiwan University Hospital Hsin-Chu Branch
  • Collaborator
    • National Yang Ming Chiao Tung University
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Yung-Chun Hsieh, MD, Study Chair, National Taiwan University Hospital Hsin-Chu Branch
  • Overall Contact(s)
    • Yung-Chun Hsieh, MD, +886-972322925, abitzsong@gmail.com

References

Hu Z, Fang C, Li B, Zhang Z, Cao C, Cai M, Su S, Sun X, Shi X, Li C, Zhou T, Zhang Y, Chi C, He P, Xia X, Chen Y, Gambhir SS, Cheng Z, Tian J. First-in-human liver-tumour surgery guided by multispectral fluorescence imaging in the visible and near-infrared-I/II windows. Nat Biomed Eng. 2020 Mar;4(3):259-271. doi: 10.1038/s41551-019-0494-0. Epub 2019 Dec 23.

van Beurden F, van Willigen DM, Vojnovic B, van Oosterom MN, Brouwer OR, der Poel HGV, Kobayashi H, van Leeuwen FWB, Buckle T. Multi-Wavelength Fluorescence in Image-Guided Surgery, Clinical Feasibility and Future Perspectives. Mol Imaging. 2020 Jan-Dec;19:1536012120962333. doi: 10.1177/1536012120962333. Review.

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