NCT05708144

NIR Fluorescent Molecular Probe for the Identification of Breast Tissue

Study of a Novel Near-infrared(NIR) Fluorescent Molecular Probe Targeting Trop-2 for the Identification of Benign and Malignant Breast Tissue

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Xiang'an Hospital of Xiamen University · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Accurate evaluation of tumor boundaries in breast-conserving surgery is critical to reducing the second operation of patients. Near-infrared (NIR) 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 identify the tumor area of the resected breast tissue during the operation and distinguish the tumor boundary. In brief, the breast tissues were incubated with the probe immediately after intraoperative resection and imaged to identify the tumor area and distinguish the tumor boundary. The accuracy of fluorescence imaging was confirmed by pathological diagnosis.

Detailed description

After enrollment, the patients received surgical treatment according to clinical diagnosis and treatment. During the operation, the excised breast tissue was incubated, and the specific procedure was as follows. 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. 2. In vitro incubation of fresh breast cancer tissues: The fresh excision breast cancer tissues were completely soaked in the incubation solution for about 10 minutes, followed by 5 minutes rinse with PBS buffer 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 tumor boundary. 4. Confirmed the diagnosis by pathological examination.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	ICG-SG incubation solution	The fresh excision breast cancer tissues were completely soaked in the incubation solution and performed fluorescence imaging.

Timeline

• Start date: 2023-02-17
• Primary completion: 2023-10-30
• Completion: 2023-10-30
• First posted: 2023-02-01
• Last updated: 2024-01-02

Locations

1 site across 1 country: China