Tumor-Targeted-NIR-II Fluorescent Molecular Probes for the Identification of Breast Cancer Tissue and SLN Metastatic Status
NCT ID: NCT06713161
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
2024-09-01
2025-12-25
Brief Summary
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Detailed Description
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1. Preparation of the incubation solution: The probe was dissolved in phosphate buffer saline(PBS) buffer as the incubation solution at room temperature in the dark,with varying concentrations (12.5, 25, 50,100 ug/mL).
2. In vitro incubation of fresh breast cancer or SLN tissues: The fresh excision breast cancer and SLN tissues were completely soaked in the incubation solution for about 1,3, 5, 7 or 10 minutes, followed by 5 minutes rinse with PBST buffer (PBS with Tween 20) and drying with the use of absorbent paper.
3. Analysis of the images in the "Digital Precision Medicine(DPM)" NIR-II system. The DPM parameter was set up before scaling. Then fluorescence imaging was performed with the DPM NIR-II system. And the result was analyzed to identify the tumor area and distinguish the metastatic status of SLN.
4. Confirmed the diagnosis by pathological examination.
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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NIR-II probe incubation
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.
NIR-II Probe(i.e ICG-POL6326) incubation solution
After the tissues were incubated with the optimal concentration of the NIR-II probe for the appropriate time, the tissues were washed with the eluate, and then the fluorescence intensity of different tissues was detected to evaluate whether the tissues had cancer tissue invasion.
Interventions
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NIR-II Probe(i.e ICG-POL6326) incubation solution
After the tissues were incubated with the optimal concentration of the NIR-II probe for the appropriate time, the tissues were washed with the eluate, and then the fluorescence intensity of different tissues was detected to evaluate whether the tissues had cancer tissue invasion.
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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Xiang'an Hospital of Xiamen University
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
Yuanyuan Zhu,Doctor
Role: backup
Weiling Chen,Doctor
Role: backup
Related Links
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Related Info
Related Info
Other Identifiers
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KYLX2024-240
Identifier Type: -
Identifier Source: org_study_id