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

May 6, 2022 updated by: National Taiwan University Hospital Hsin-Chu Branch
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

24

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Taiwan
    • HsinChu County
      • Zhubei, HsinChu County, Taiwan, 302
        • Recruiting
        • National Taiwan University Hospital Hsin-Chu Branch BioMedical Park Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Signal-to-background ratio (SBR)
Time Frame: 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.
through study completion, an average of 1 year
Penetration depth
Time Frame: through study completion, an average of 1 year
Evaluates the depth of the deepest visualized subcutaneous lymphatics in the breast
through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sentinel lymph nodes pathology
Time Frame: through study completion, an average of 1 year
The positivity and number of retrieved sentinel lymph nodes at definitive pathology report.
through study completion, an average of 1 year
Time to total visualization of breast subcutaneous lymphatics
Time Frame: through study completion, an average of 1 year
The time from injection of indocyanine green to total visualization of breast subcutaneous lymphatics
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital Hsin-Chu Branch

Collaborators

National Yang Ming Chiao Tung University

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 8, 2022

Primary Completion (Anticipated)

April 7, 2023

Study Completion (Anticipated)

April 7, 2023

Study Registration Dates

First Submitted

April 27, 2022

First Submitted That Met QC Criteria

May 6, 2022

First Posted (Actual)

May 9, 2022

Study Record Updates

Last Update Posted (Actual)

May 9, 2022

Last Update Submitted That Met QC Criteria

May 6, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 111-009-F

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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