Breast Cancer, Sentinel Lymph Node
Conditions
Keywords
Indocyanine green, Sentinel lymph node biopsy, Axillary lymph node dissection
Brief summary
A study for dosage-image optimization of 6% hydroxyethyl starch diluted indocyanine green for near-infrared fluorescence navigated sentinel lymph node mapping for breast cancer patient.
Detailed description
Pre-clinical experiment has shown using 6% hydroxyethyl starch (Voluven®) as a solvent, compared with pure water, can improve brightness of indocyanine green particles at the same concentration. Similar findings have been addressed using human serum albumin as a solvent for indocyanine green in previous studies, but there was no report using 6% hydroxyethyl starch as a solvent till now. This study aims for clinical translation and optimization of 6% hydroxyethyl starch diluted indocyanine green in breast cancer patients undergoing sentinel lymph node biopsy.
Interventions
Patient will undergo sentinel lymph node biopsy with near infrared fluorescence navigation. The dosage of ICG will not exceed 2.5 mg in total, and the volume of the assigned solvent will not exceed 5 mL in total.
Sponsors
National Yang Ming Chiao Tung University
National Taiwan University Hospital Hsin-Chu Branch
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)
Masking description
The participant will know how many concentration ladders we have, but will not know the exact concentration used on him.
Intervention model description
The participants will be assigned to sentinel lymph node biopsies using different concentrations of voluven based indocyanine green. Estimated concentration grouping (ICG mg / Voluven mL): 2.5, 0.5, 0.25, 0.125, 0.0625. Planned recruiting at least 3 participants in each diluted concentration group. The dilution rate will advance if imaging quality is improving compared with the last concentration group. The study will be completed if the best imaging quality injection protocol is found.
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. |
| Penetration depth | through study completion, an average of 1 year | Evaluates the depth of the deepest visualized subcutaneous lymphatics in the breast |
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. |
| Time to total visualization of breast subcutaneous lymphatics | through study completion, an average of 1 year | The time from injection of indocyanine green to total visualization of breast subcutaneous lymphatics |
Countries
Taiwan
Contacts
Primary ContactYung-Chun Hsieh, MD
Backup ContactYang-Hsiang Chan, PhD
Outcome results
None listed