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

Breast Cancer Clinical Trial

Official title:

Development and Utilization of Indocyanine Green Fluorescence Near Infrared Zone II Lymphography in Breast Cancer Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05365191
• Other study ID #: 110-163-F
• Status: Recruiting
• Phase: N/A
• Start date: April 8, 2022
• Est. completion date: April 7, 2023

Study information

• Verified date: May 2022
• Source: National Taiwan University Hospital Hsin-Chu Branch
• Contact: Yung-Chun Hsieh, MD
• Phone: +886-972322925
• Email: abitzsong[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: April 7, 2023
• Est. primary completion date: April 7, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Sentinel Lymph Node

Intervention

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.

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital Hsin-Chu Branch Biomedical Park Hospital	Zhubei	HsinChu County

Sponsors (2)

Lead Sponsor	Collaborator
National Taiwan University Hospital Hsin-Chu Branch	National Yang Ming Chiao Tung University

Country where clinical trial is conducted

Taiwan, 

References & Publications (2)

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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Signal-to-background ratio (SBR)	Evaluates the SBR of the near-infrared fluorescence between the retrieved sentinel lymph nodes and the background.	through study completion, an average of 1 year
Secondary	Sentinel lymph nodes pathology	The positivity and number of retrieved sentinel lymph nodes at definitive pathology report.	through study completion, an average of 1 year
Secondary	Penetration depth	Evaluates the depth of the deepest visualized subcutaneous lymphatics in the breast	through study completion, an average of 1 year