NIR Fluorescent Molecular Probe for the Identification of Breast Tissue

Breast Cancer Clinical Trial

— NIR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05708144
• Other study ID #: XianganHXiamenU
• Status: Completed
• Phase: N/A
• Start date: February 17, 2023
• Est. completion date: October 30, 2023

Study information

• Verified date: December 2023
• Source: Xiang'an Hospital of Xiamen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: October 30, 2023
• Est. primary completion date: October 30, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult patients over 18 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.

Related Conditions & MeSH terms

• Breast Cancer

Intervention

Diagnostic Test:
• ICG-SG incubation solution
The fresh excision breast cancer tissues were completely soaked in the incubation solution and performed fluorescence imaging.

Locations

Country	Name	City	State
China	Xiamen Key Laboratory of Endocrine-Related Cancer Precision Medicine	Xiamen	Fujian

Sponsors (1)

Lead Sponsor	Collaborator
Xiang'an Hospital of Xiamen University

Country where clinical trial is conducted

China, 

References & Publications (1)

Li C, Mi J, Wang Y, Zhang Z, Guo X, Zhou J, Hu Z, Tian J. New and effective EGFR-targeted fluorescence imaging technology for intraoperative rapid determination of lung cancer in freshly isolated tissue. Eur J Nucl Med Mol Imaging. 2023 Jan;50(2):494-507. doi: 10.1007/s00259-022-05975-7. Epub 2022 Oct 8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Expression of the trop-2 in the tumor	Ability of the imaging system to detect the expression of the trop-2 in the mass (i.e tumor).	2 years
Primary	Uptake of the dye by the tumor	Ability of the imaging system to discern the uptake of the dye by the tumor. Detected with imaging probe.	2 years
Primary	False positive rates of ICG-SG	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 Trop2-positive tumors) rates of ICG-SG.	2 years
Secondary	Incidence rates of all adverse events (AEs)	Tissue incubation adverse events and adverse device events (ADEs)	2 years

External Links

•   A new fluorescence imaging technology for intraoperative rapid determination of lung cancer in freshly isolated tissue