A Study Evaluating Near-infrared Zone II Imaging in Sentinel Lymph Node Mapping in Breast Cancer Patients
NCT ID: NCT05365191
Last Updated: 2022-05-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
30 participants
INTERVENTIONAL
2022-04-08
2023-04-07
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study for Optimization of 6% Hydroxyethyl Starch Based Indocyanine Green Near-infrared Fluorescence Navigated Sentinel Lymph Node Biopsy for Breast Cancer Patients
NCT05365204
Real-Time Near-infrared (NIR) Mapping of Sentinel Lymph Nodes in Breast Cancer
NCT01468649
Sentinel Lymph Node Biopsy in Breast Cancer Surgery Using ICG
NCT03579979
Near-Infrared Fluorescent Sentinel Lymph Node Mapping for Breast Cancer
NCT00721370
Cost of Using FLUOrescence to Green of Indocyanine for the Detection of Breast Cancer.
NCT05699291
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Multispectral near infrared imaging
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.
Near infrared fluorescence navigated sentinel lymph node mapping
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Near infrared fluorescence navigated sentinel lymph node mapping
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
* 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
20 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Yang Ming Chiao Tung University
OTHER
National Taiwan University Hospital Hsin-Chu Branch
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Yung-Chun Hsieh, MD
Role: STUDY_CHAIR
National Taiwan University Hospital Hsin-Chu Branch
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
National Taiwan University Hospital Hsin-Chu Branch Biomedical Park Hospital
Zhubei, HsinChu County, Taiwan
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
110-163-F
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.