Back to resultsA Study Evaluating Near-infrared Zone II Imaging in Sentinel Lymph Node Mapping in Breast Cancer Patients
Primary Purpose
Breast Cancer, Sentinel Lymph Node
Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Near infrared fluorescence navigated sentinel lymph node mapping
Sponsored by
About this trial
This is an interventional basic science trial for Breast Cancer focused on measuring Indocyanine green, Image-guided surgery, Multispectral fluorescence imaging
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
Sites / Locations
- National Taiwan University Hospital Hsin-Chu Branch Biomedical Park HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Multispectral near infrared imaging
Arm 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.
Outcomes
Primary Outcome Measures
Signal-to-background ratio (SBR)
Evaluates the SBR of the near-infrared fluorescence between the retrieved sentinel lymph nodes and the background.
Secondary Outcome Measures
Sentinel lymph nodes pathology
The positivity and number of retrieved sentinel lymph nodes at definitive pathology report.
Penetration depth
Evaluates the depth of the deepest visualized subcutaneous lymphatics in the breast
Full Information
NCT ID
NCT05365191
First Posted
April 27, 2022
Last Updated
May 6, 2022
Sponsor
National Taiwan University Hospital Hsin-Chu Branch
Collaborators
National Yang Ming Chiao Tung University
1. Study Identification
Unique Protocol Identification Number
NCT05365191
Brief Title
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
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 8, 2022 (Actual)
Primary Completion Date
April 7, 2023 (Anticipated)
Study Completion Date
April 7, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital Hsin-Chu Branch
Collaborators
National Yang Ming Chiao Tung University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Sentinel Lymph Node
Keywords
Indocyanine green, Image-guided surgery, Multispectral fluorescence imaging
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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.
Masking
None (Open Label)
Masking Description
The patient will know they are going to accept near infrared zone II imaging during the sentinel lymph node biopsy procedure. They will not see the images and will not know the quality results.
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Multispectral near infrared imaging
Arm Type
Other
Arm 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.
Intervention Type
Procedure
Intervention Name(s)
Near infrared fluorescence navigated sentinel lymph node mapping
Intervention Description
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.
Primary Outcome Measure Information:
Title
Signal-to-background ratio (SBR)
Description
Evaluates the SBR of the near-infrared fluorescence between the retrieved sentinel lymph nodes and the background.
Time Frame
through study completion, an average of 1 year
Secondary Outcome Measure Information:
Title
Sentinel lymph nodes pathology
Description
The positivity and number of retrieved sentinel lymph nodes at definitive pathology report.
Time Frame
through study completion, an average of 1 year
Title
Penetration depth
Description
Evaluates the depth of the deepest visualized subcutaneous lymphatics in the breast
Time Frame
through study completion, an average of 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yung-Chun Hsieh, MD
Phone
+886-972322925
Email
abitzsong@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yang-Hsiang Chan, PhD
Phone
+886-966626689
Email
yhchan@nycu.edu.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yung-Chun Hsieh, MD
Organizational Affiliation
National Taiwan University Hospital Hsin-Chu Branch
Official's Role
Study Chair
Facility Information:
Facility Name
National Taiwan University Hospital Hsin-Chu Branch Biomedical Park Hospital
City
Zhubei
State/Province
HsinChu County
ZIP/Postal Code
302
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yung-Chun Hsieh, MD
Phone
+886-972322925
Email
abitzsong@gmail.com
12. IPD Sharing Statement
Citations:
PubMed Identifier
31873212
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.
Results Reference
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PubMed Identifier
33125289
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.
Results Reference
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A Study Evaluating Near-infrared Zone II Imaging in Sentinel Lymph Node Mapping in Breast Cancer Patients
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