Breast Cancer, Sentinel Lymph Node
Conditions
Keywords
Indocyanine green, Image-guided surgery, Multispectral fluorescence imaging
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.
Interventions
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.
Sponsors
National Yang Ming Chiao Tung University
National Taiwan University Hospital Hsin-Chu Branch
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
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.
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.
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Taiwan
Contacts
Primary ContactYung-Chun Hsieh, MD
Backup ContactYang-Hsiang Chan, PhD
Outcome results
None listed