Tumor-Targeted-NIR-II Fluorescent Molecular Probes for the Identification of Breast Cancer Tissue and SLN Metastatic Status

Recruiting

• Conditions: Breast Cancer; Sentinel Lymph Node; Metastases; Margin Assessment

• Registration Number: NCT06713161
• Lead Sponsor: Yunnan Cancer Hospital

Brief Summary

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.

Detailed Description

After enrollment, the patients received surgical treatment according to clinical diagnosis and treatment.During the operation, the excised breast tissue and SLN 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,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.

Study Timeline

• Study Start: 2024-09-01
• Status Verified: 2024-11
• Study First Submitted: 2024-11-27
• Study First Submitted QC: 2024-11-27
• Last Update Submitted: 2024-11-27
• Study First Posted: 2024-12-03
• Last Update Posted: 2024-12-03
• Primary Completion: 2025-08-25
• Study Completion: 2025-12-25

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 40

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Expression of the CXCR4 in the tumor	2 year	Ability of the imaging system to detect the expression of the CXCR4 in the mass (i.e tumor).
Uptake of the dye by the tissue(i.e tumor,metastatic SLN)	2 year	Ability of the imaging system to discern the uptake of the dye by the tumor or metastatic SLN . Detected with imaging probe.
False positive rates of the NIR-II probe (ICG-POL6326)	2 year	Microscopic examination and immunohistochemistry of tumor performed by a pathologist. This will allow investigators to compare pathology results with fluorescence images taken by imaging probe to calculate false positive (i.e., identification of non CXCR4-positive tumors) rates of ICG-POL6326.

Trial Locations

Locations (1)

Yunnan Cancer Hospital; 🇨🇳 Kunming, Yunnan, China