Clinical trial NCT05365191: A Study Evaluating Near-infrared Zone II Imaging in Sentinel Lymph Node Mapping in Breast Cancer Patients
Official title: Development and Utilization of Indocyanine Green Fluorescence Near Infrared Zone II Lymphography in Breast Cancer Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Cancer
Sentinel Lymph Node
Keywords: Indocyanine green
Image-guided surgery
Multispectral fluorescence imaging
Lead sponsor: National Taiwan University Hospital Hsin-Chu Branch
Sponsor class: OTHER
Collaborators: name: National Yang Ming Chiao Tung University
First posted: 2022-05-09
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model 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.
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Signal-to-background ratio (SBR)
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Sentinel lymph nodes pathology
timeFrame: through study completion, an average of 1 year
measure: Penetration depth
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Zhubei
country: Taiwan
facility: National Taiwan University Hospital Hsin-Chu Branch Biomedical Park Hospital
state: HsinChu County
Study officials:
affiliation: National Taiwan University Hospital Hsin-Chu Branch
name: Yung-Chun Hsieh, MD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.