NCT05365191

Brief Summary

This study aims for evaluating near infrared zone II imaging in sentinel lymph node mapping in breast cancer patients.

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
30

participants targeted

Target at below P25 for not_applicable breast-cancer

Timeline
Completed

Started Apr 2022

Shorter than P25 for not_applicable 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 greenImage-guided surgeryMultispectral fluorescence imaging

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (2)

  • Sentinel lymph nodes pathology

    through study completion, an average of 1 year

  • Penetration depth

    through study completion, an average of 1 year

Study Arms (1)

Multispectral near infrared imaging

OTHER

The participants will be assigned to one single arm that accepted both near infrared zone I and near infrared zone II imaging during the near infrared fluorescence navigated sentinel lymph node biopsy procedure. Imaging quality will be compared between different spectrums.

Procedure: Near infrared fluorescence navigated sentinel lymph node mapping

Interventions

Near infrared fluorescence navigated sentinel lymph node mappingPROCEDURE

Participants undergo sentinel lymph node biopsy for breast cancer, and use blue dye/Tc99m radioisotope as primary tracer. Indocyanine green near infrared fluorescence as secondary tracer for mapping.

Multispectral near infrared imaging

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 (2)

  • Hu Z, Fang C, Li B, Zhang Z, Cao C, Cai M, Su S, Sun X, Shi X, Li C, Zhou T, Zhang Y, Chi C, He P, Xia X, Chen Y, Gambhir SS, Cheng Z, Tian J. First-in-human liver-tumour surgery guided by multispectral fluorescence imaging in the visible and near-infrared-I/II windows. Nat Biomed Eng. 2020 Mar;4(3):259-271. doi: 10.1038/s41551-019-0494-0. Epub 2019 Dec 23.

    PMID: 31873212BACKGROUND

  • van Beurden F, van Willigen DM, Vojnovic B, van Oosterom MN, Brouwer OR, der Poel HGV, Kobayashi H, van Leeuwen FWB, Buckle T. Multi-Wavelength Fluorescence in Image-Guided Surgery, Clinical Feasibility and Future Perspectives. Mol Imaging. 2020 Jan-Dec;19:1536012120962333. doi: 10.1177/1536012120962333.

    PMID: 33125289BACKGROUND

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
not applicable
Allocation
NA
Masking
NONE
Masking Details
The patient will know they are going to accept near infrared zone II imaging during the sentinel lymph node biopsy procedure. They will not see the images and will not know the quality results.
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Model Details: The participants will be assigned to one single arm that accepted both near infrared zone I and near infrared zone II imaging during the near infrared fluorescence navigated sentinel lymph node biopsy procedure.
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)