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Study identifier: NCT06911528 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

Application of EndoScell Intraoperative Cellular Probing Technology for Early-Stage Breast Cancer

Condition: Breast Cancer · Sentinel Lymph Node · Frozen Section  ·  Sponsor: Fudan University

PhaseNA
Planned participants709
Who can joinFemale, 18 Years to no upper limit
Healthy volunteersNo

About this study

Sentinel Lymph Node Biopsy (SLNB) is a common surgical treatment for breast cancer and a primary method for assessing the pathological status of axillary lymph nodes. Precise intraoperative detection of sentinel lymph nodes during surgery assists in timely evaluation of axillary lymph node pathology and helps in formulating further treatment strategies. Touch imprint cytology (TIC) is one of the most commonly used intraoperative detection techniques. The new intraoperative cellular detection technology, EndoScell Scanner (ES), uses an improved real-time miniaturized fluorescence microscopy system for image acquisition. The ultra-high-resolution images obtained can reach the cellular level. In previous studies, the accuracy and sensitivity of this technology for intraoperative detection of sentinel lymph nodes were comparable to imprint cytology, but it is much more rapid. The detection technology uses fluorescein sodium and methylene blue as fluorescent dyes, which is non-invasive and also non-consumptive of tissue samples. This study involves patients scheduled for sentinel lymph node biopsy and aims to evaluate the clinical application value of the EndoScell Scanner (ES) for intraoperative assessment of the pathological status of sentinel lymph nodes through a prospective self-controlled study. To avoid the potential impact of methylene blue on the ES detection technology, we will use mitoxantrone as a new dye for sentinel lymph node tracing in this study. The primary st…

This description comes directly from the study's public registry record.

Talk to the study team

Jiajian Chen, Doctor  ·  +8618017317219  ·  elwin1020@163.com

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Locations (1)

Fudan University Shanghai Cancer CenterShanghai, Shanghai Municipality, ChinaRecruiting

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Source record: clinicaltrials.gov/study/NCT06911528