Trop2-targeting NIR-II Molecular Probe for Breast Cancer Precise Surgery
NCT ID: NCT06713681
Last Updated: 2024-12-03
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
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RECRUITING
40 participants
OBSERVATIONAL
2024-05-13
2025-12-31
Brief Summary
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Detailed Description
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1. Preparation of the incubation solution: TTP-ICG will be dissolved in phosphate-buffered saline (PBS) at room temperature in the dark, with varying concentrations (5, 10, 20 μg/mL).
2. Incubation of fresh breast masses or lymph nodes: The freshly excised breast masses or lymph nodes will be immersed and gently agitated in the incubation solution for 3, 5, or 10 minutes. Subsequently, they will be rinsed with PBST buffer (PBS with Tween 20) for 5 minutes and dried using absorbent paper.
3. Acquisition of NIR-II images: NIR-II images and fluorescent intensities will be captured using the "Digital Precision Medicine (DPM)" NIR-II system, optimized with appropriate parameters.
4. Pathological diagnosis and data analysis: Hematoxylin and eosin staining, along with immuno-histochemistry, will be performed. The subsequent correlation between pathological characterization and fluorescent information will be further analyzed.
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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TTP-ICG incubation
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.
TTP-ICG incubation solution
Fresh breast massed and lymph nodes will be incubated with TTP-ICG with different concentrations and times
Interventions
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TTP-ICG incubation solution
Fresh breast massed and lymph nodes will be incubated with TTP-ICG with different concentrations and times
Eligibility Criteria
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Inclusion Criteria
* 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 had contraindications to surgery, such as serious cardiopulmonary disease, coagulation dysfunction, etc
* Other conditions that the researcher considers inappropriate to participate in the study
18 Years
75 Years
FEMALE
No
Sponsors
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Affiliated Cancer Hospital of Shantou University Medical College
OTHER
Yunnan Cancer Hospital
OTHER
Responsible Party
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Locations
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Yunnan Cancer Hospital
Kunming, Yunnan, China
Countries
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Central Contacts
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Facility Contacts
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Guojun Zhang, Doctor
Role: backup
Kangliang Lou, Doctor
Role: backup
Jingwen Bai, Doctor
Role: backup
References
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Chen 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.
Other Identifiers
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KYLX2024-140
Identifier Type: -
Identifier Source: org_study_id