Clinical trial · Observational
Tumor-Targeted-NIR-II Fluorescent Molecular Probes for the Identification of Breast Cancer Tissue and SLN Metastatic Status
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Accurate evaluation of tumor boundaries in breast-conserving surgery is closely associated with reducing the second operation of patients. Meanwhile, accurately assessing sentinel lymph node (SLN) metastasis is crucial for determining the extent of axillary lymph node dissection (ALND) and minimizing complications. Near-infrared-II (NIR-II) fluorescence imaging using molecular agents has shown promise for in situ imaging during resection. However, very effective probes can be applied to clinical trials up to now, which limits the clinical application of fluorescence imaging. Here we developed a new technology that can quickly differentiation between cancer and para-cancer tissue as well as metastatic and normal sentinel lymph nodes(SLN). In brief, the fresh tissues were incubated with the probe immediately after intraoperative resection and imaged to identify the tumor area and distinguish the metastatic status of SLN. The accuracy of fluorescence imaging was confirmed by pathological diagnosis.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Margin Assessment | — | UNRESOLVED | — |
| Metastases | Breast Neoplasm | PROBABILISTIC | 0.70 |
| Sentinel Lymph Node | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| NIR-II Probe(i.e ICG-POL6326) incubation solution | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- NIR-II probe incubation
- description
- The fresh excision breast tissues or SLN will be completely soaked in the NIR-II probe (i.e:ICG-POL6326) incubation solution (12.5,25,50,100 ug/mL) for1, 3, 5,7 or 10 min, followed by 5 min of rinsing with PBST buffer and drying with absorbent paper.The NIR-II fluorescence imaging will be then performed under the DPM NIR-II system. And the correlation between pathological characterization and fluorescent information will be further analyzed.
- interventionNames
- Diagnostic Test: NIR-II Probe(i.e ICG-POL6326) incubation solution
Primary outcomes (3)
- measure
- Expression of the CXCR4 in the tumor
- timeFrame
- 2 year
- description
- Ability of the imaging system to detect the expression of the CXCR4 in the mass (i.e tumor).
- measure
- Uptake of the dye by the tissue(i.e tumor,metastatic SLN)
- timeFrame
- 2 year
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Adult patients between 18-75 years of age * Female * Patients presenting with a breast nodule or mass presumed to be resectable on pre-operative assessment * Good operative candidate * Subject capable of giving informed consent and participating in the process of consent Exclusion Criteria: * Patients unable to participate in the consent process * Patients had contraindications to surgery, such as serious cardiopulmonary disease, coagulation dysfunction, etc * Other conditions that the researcher considers inappropriate to participate in the study
References
Publications (0)
Data not yet available