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

• Sponsor: National Taiwan University Hospital Hsin-Chu Branch (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05365204
• Collaborator: National Yang Ming Chiao Tung University (Other)
• Enrollment: 24
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 12
• Patients Per Site Per Month: 2

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer; Sentinel Lymph Node	Procedure: Near infrared fluorescence navigated sentinel lymph node mapping	Phase 1

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 24 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• 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.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: Single (Participant)
• Masking Description: The participant will know how many concentration ladders we have, but will not know the exact concentration used on him.
• Primary Purpose: Basic Science
• 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
• Actual Study Start Date: Apr 8, 2022
• Anticipated Primary Completion Date: Apr 7, 2023
• Anticipated Study Completion Date: Apr 7, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Voluven diluted indocyanine green This arm participants uses Voluven diluted ICG for sentinel lymph node mapping.	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.
Active Comparator: Distilled-water diluted indocyanine green This arm participants uses Distilled-water diluted ICG for sentinel lymph node mapping.	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.

Outcome Measures

Primary Outcome Measures

1. 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.

2. Penetration depth [through study completion, an average of 1 year]

   Evaluates the depth of the deepest visualized subcutaneous lymphatics in the breast

Secondary Outcome Measures

1. 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.

2. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	National Taiwan University Hospital Hsin-Chu Branch Biomedical Park Hospital	Zhubei	HsinChu County	Taiwan	302

Sponsors and Collaborators

• National Taiwan University Hospital Hsin-Chu Branch
• National Yang Ming Chiao Tung University

Investigators

• Study Chair: Yung-Chun Hsieh, MD, National Taiwan University Hospital Hsin-Chu Branch

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.

• Responsible Party: National Taiwan University Hospital Hsin-Chu Branch
• ClinicalTrials.gov Identifier: NCT05365204
• Other Study ID Numbers: 111-009-F
• First Posted: May 9, 2022
• Last Update Posted: May 9, 2022
• Last Verified: May 1, 2022

• 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
• Keywords provided by National Taiwan University Hospital Hsin-Chu Branch: Indocyanine green; Sentinel lymph node biopsy; Axillary lymph node dissection
• Additional relevant MeSH terms: Breast Neoplasms

Study Results

No Results Posted as of May 9, 2022