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NCT06911528: EDGE
Application of EndoScell Intraoperative Cellular Probing Technology for Early-Stage Breast Cancer
NA trial testing EndoScell Scaner (ES) novel intraoperative cellular probing technology in Breast Cancer in 709 participants. Currently enrolling.
31 December 2025
Quick facts
| Lead sponsor | Fudan University |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | diagnostic |
| Enrollment | 709 |
| Start date | 30 January 2024 |
| Primary completion | 31 December 2025 |
| Estimated completion | 31 December 2025 |
| Sites | 1 location across China |
Drugs / interventions tested
- EndoScell Scaner (ES) novel intraoperative cellular probing technology
Conditions studied
- Breast Cancer — all drugs for Breast Cancer →
- Sentinel Lymph Node — all drugs for Sentinel Lymph Node →
- Frozen Section — all drugs for Frozen Section →
- Cytology — all drugs for Cytology →
Sponsor
Fudan University
Who can join
18 and older, female only, with Breast Cancer or Sentinel Lymph Node. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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 study objective is to compare the accuracy of the ES detection technology in assessing sentinel lymph node status, using paraffin pathology examination as the gold standard. The primary endpoint is the accuracy of the ES technology. Secondary endpoints include the image quality score of the ES detection, the learning curve of the surgeons, and the time required for detection.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06911528
- Europe PMC full search
- ASCO Meeting Library
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- bioRxiv preprints
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06911528 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Fudan University
- Last refreshed: 4 April 2025
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