Clinical trial · Observational
Trop2-targeting NIR-II Molecular Probe for Breast Cancer Precise Surgery
Trop2-targeting the Second Near Infrared (NIR-II) Molecular Probe for the Ex Vivo Evaluation of Breast Cancer Surgical Margin and Lymph Node Metastasis 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)
Positive surgical margins are closely associated with local recurrence in breast-conserving surgery (BCS). Meanwhile, accurately assessing sentinel lymph node (SLN) metastasis is crucial for determining the extent of axillary lymph node dissection (ALND) and minimizing complications. Indocyanine green (ICG)-based the second near-infrared (NIR-II) fluorescence imaging offers real-time visualization during surgery, potentially reducing positive margin rates and improving SLN detection, while the specificity remains a challenge. Herein, the investigators will introduce a novel NIR-II probe, TTP-ICG, based on a Trop2-targeting peptide and an approach which enables rapid differentiation between cancer and para-cancer tissue as well as metastatic and normal lymph nodes. In brief, fresh tissues will be soaked in TTP-ICG immediately after resection, and their histological characterization will be determined under NIR-II fluorescence imaging. Pathological confirmation will further validate our approach.
Conditions
Conditions (3)
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 |
| Margins of Excision | — | UNRESOLVED | — |
| Sentinel Lymph Node | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| TTP-ICG incubation solution | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- TTP-ICG incubation
- description
- The fresh excision breast masses or lymph nodes will be completely soaked in the TTP-ICG incubation solution (5, 10, 20 μg/mL) for 3, 5, 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: TTP-ICG incubation solution
Primary outcomes (2)
- measure
- Differentiation of breast cancer, para-cancer tissues, and benign masses as well as metastatic and normal lymph nodes
- timeFrame
- 1 year
- description
- NIR-II fluorescence intensity of breast cancer, para-cancer tissues, and benign masses as well as metastatic and normal lymph nodes after TTP-ICG incubation .
- measure
- Expression of the Trop-2 in the breast cancer and metastatic lymph nodes
- timeFrame
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 (1)
- BACKGROUNDChen W, Zhang Y, Zhang L, Luo X, Yang X, Zhu Y, Wang G, Huang W, Zhang D, Zeng Y, Li R, Guo C, Wang J, Wu Z, Liu N, Zhang G. Intraoperative evaluation of tumor margins using a TROP2 near-infrared imaging probe to enable human breast-conserving surgery. Sci Transl Med. 2024 Oct 16;16(769):eado2461. doi: 10.1126/scitranslmed.ado2461. Epub 2024 Oct 16. PMID 39413161