Back to resultsA Study for Optimization of 6% Hydroxyethyl Starch Based Indocyanine Green Near-infrared Fluorescence Navigated Sentinel Lymph Node Biopsy for Breast Cancer Patients
Primary Purpose
Breast Cancer, Sentinel Lymph Node
Status
Recruiting
Phase
Phase 1
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, Sentinel lymph node biopsy, Axillary lymph node dissection
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 2
Arm Type
Experimental
Active Comparator
Arm Label
Voluven diluted indocyanine green
Distilled-water diluted indocyanine green
Arm Description
This arm participants uses Voluven diluted ICG for sentinel lymph node mapping.
This arm participants uses Distilled-water diluted ICG for sentinel lymph node mapping.
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.
Penetration depth
Evaluates the depth of the deepest visualized subcutaneous lymphatics in the breast
Secondary Outcome Measures
Sentinel lymph nodes pathology
The positivity and number of retrieved sentinel lymph nodes at definitive pathology report.
Time to total visualization of breast subcutaneous lymphatics
The time from injection of indocyanine green to total visualization of breast subcutaneous lymphatics
Full Information
NCT ID
NCT05365204
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
NCT05365204
Brief Title
A Study for Optimization of 6% Hydroxyethyl Starch Based Indocyanine Green Near-infrared Fluorescence Navigated Sentinel Lymph Node Biopsy for Breast Cancer Patients
Official Title
A Study for Optimization of 6% Hydroxyethyl Starch Based Indocyanine Green Near-infrared Fluorescence Navigated Sentinel Lymph Node Biopsy for 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
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
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, Sentinel lymph node biopsy, Axillary lymph node dissection
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
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.
Masking
Participant
Masking Description
The participant will know how many concentration ladders we have, but will not know the exact concentration used on him.
Allocation
Randomized
Enrollment
24 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Voluven diluted indocyanine green
Arm Type
Experimental
Arm Description
This arm participants uses Voluven diluted ICG for sentinel lymph node mapping.
Arm Title
Distilled-water diluted indocyanine green
Arm Type
Active Comparator
Arm Description
This arm participants uses Distilled-water diluted ICG for sentinel lymph node mapping.
Intervention Type
Procedure
Intervention Name(s)
Near infrared fluorescence navigated sentinel lymph node mapping
Intervention Description
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.
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
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
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
Time to total visualization of breast subcutaneous lymphatics
Description
The time from injection of indocyanine green to total visualization of breast subcutaneous lymphatics
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
21360250
Citation
Mieog JS, Troyan SL, Hutteman M, Donohoe KJ, van der Vorst JR, Stockdale A, Liefers GJ, Choi HS, Gibbs-Strauss SL, Putter H, Gioux S, Kuppen PJ, Ashitate Y, Lowik CW, Smit VT, Oketokoun R, Ngo LH, van de Velde CJ, Frangioni JV, Vahrmeijer AL. Toward optimization of imaging system and lymphatic tracer for near-infrared fluorescent sentinel lymph node mapping in breast cancer. Ann Surg Oncol. 2011 Sep;18(9):2483-91. doi: 10.1245/s10434-011-1566-x. Epub 2011 Mar 1.
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A Study for Optimization of 6% Hydroxyethyl Starch Based Indocyanine Green Near-infrared Fluorescence Navigated Sentinel Lymph Node Biopsy for Breast Cancer Patients
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