NCT05365204

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
24

participants targeted

Target at P25-P50 for phase_1 breast-cancer

Timeline
Completed

Started Apr 2022

Shorter than P25 for phase_1 breast-cancer

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 8, 2022

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

April 27, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 9, 2022

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 7, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 7, 2023

Completed
Last Updated

May 9, 2022

Status Verified

May 1, 2022

Enrollment Period

12 months

First QC Date

April 27, 2022

Last Update Submit

May 6, 2022

Conditions

Breast CancerSentinel Lymph Node

Keywords

Indocyanine greenSentinel lymph node biopsyAxillary lymph node dissection

Outcome Measures

Primary Outcomes (2)

  • 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

  • Penetration depth

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

    through study completion, an average of 1 year

Secondary Outcomes (2)

  • Sentinel lymph nodes pathology

    through study completion, an average of 1 year

  • Time to total visualization of breast subcutaneous lymphatics

    through study completion, an average of 1 year

Study Arms (2)

Voluven diluted indocyanine green

EXPERIMENTAL

This arm participants uses Voluven diluted ICG for sentinel lymph node mapping.

Procedure: Near infrared fluorescence navigated sentinel lymph node mapping

Distilled-water diluted indocyanine green

ACTIVE COMPARATOR

This arm participants uses Distilled-water diluted ICG for sentinel lymph node mapping.

Procedure: Near infrared fluorescence navigated sentinel lymph node mapping

Interventions

Near infrared fluorescence navigated sentinel lymph node mappingPROCEDURE

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.

Distilled-water diluted indocyanine greenVoluven diluted indocyanine green

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Breast cancer, adults

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital Hsin-Chu Branch Biomedical Park Hospital

Zhubei, HsinChu County, 302, Taiwan

RECRUITING

Related 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, 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.

    PMID: 21360250BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Yung-Chun Hsieh, MD

    National Taiwan University Hospital Hsin-Chu Branch

    STUDY CHAIR

Central Study Contacts

Yung-Chun Hsieh, MD

CONTACT

+886-972322925abitzsong@gmail.com

Yang-Hsiang Chan, PhD

CONTACT

+886-966626689yhchan@nycu.edu.tw

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
The participant will know how many concentration ladders we have, but will not know the exact concentration used on him.
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 27, 2022

First Posted

May 9, 2022

Study Start

April 8, 2022

Primary Completion

April 7, 2023

Study Completion

April 7, 2023

Last Updated

May 9, 2022

Record last verified: 2022-05

Locations

TW(1)