A Study for Optimization of 6% Hydroxyethyl Starch Based Indocyanine Green Near-infrared Fluorescence Navigated Sentinel Lymph Node Biopsy for Breast Cancer Patients

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05365204
• Other study ID #: 111-009-F
• Status: Recruiting
• Phase: Phase 1
• 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

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• 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
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.

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 (1)

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, Löwik 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. — 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
Primary	Penetration depth	Evaluates the depth of the deepest visualized subcutaneous lymphatics in the breast	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	Time to total visualization of breast subcutaneous lymphatics	The time from injection of indocyanine green to total visualization of breast subcutaneous lymphatics	through study completion, an average of 1 year