Xiamen Key Laboratory of Endocrine-Related Cancer Precision Medicine
Xiamen, Fujian, 361000, China
NCT Number: NCT05708144
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.
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Notify Me18 year and older
Female
Interventional
Not applicable
Xiamen, Fujian, 361000, China
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The fresh excision breast cancer tissues were completely soaked in the incubation solution and performed fluorescence imaging.
Time frame: 2 years
Ability of the imaging system to detect the expression of the trop-2 in the mass (i.e tumor).
Time frame: 2 years
Ability of the imaging system to discern the uptake of the dye by the tumor. Detected with imaging probe.
Time frame: 2 years
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.
Time frame: 2 years
Tissue incubation adverse events and adverse device events (ADEs)
Xiang'an Hospital of Xiamen University
Other
Study of a Novel Near-infrared(NIR) Fluorescent Molecular Probe Targeting Trop-2 for the Identification of Benign and Malignant Breast Tissue
Acronym: NIR
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