Trop2-targeting NIR-II Molecular Probe for Precision Diagnosis of Oral Cancer

Trop2-targeting the Second Near Infrared (NIR-II) Molecular Probe for Precision Diagnosis of Oral Cancer

Given the morphological and clinical similarities between certain oral malignant neoplasms and benign conditions such as oral ulcerations or inflammatory lesions, the potential for misdiagnosis is significant. Currently, histopathological examination via tissue biopsy remains the diagnostic gold standard; however, this approach is inherently invasive and may yield incomplete diagnostic results due to sampling limitations and spatial heterogeneity of the lesion. These challenges underscore the urgent need for the development of simple, non-invasive, cost-effective, and real-time in vivo imaging modalities. To address this, the investigators propose the utilization of a previously developed near-infrared II (NIR-II) fluorescent molecular imaging probe, TTP-ICG, which exhibits high specificity for TROP2, a transmembrane glycoprotein frequently overexpressed in oral squamous cell carcinoma (OSCC). This study will evaluate the diagnostic accuracy of OSCC through localized application of the TROP2-targeted probe via clinical specimens being soaked in TTP-ICG solution. Furthermore, the investigators aim to explore the feasibility of employing a mouth wash-based delivery system for the probe, with the ultimate goal of establishing a precise, minimally invasive, and cost-effective real-time imaging strategy for the early detection and diagnosis of OSCC. Such an approach has the potential to significantly enhance diagnostic precision, improve patient outcomes, and increase survival rates.

After participants enrollment, surgical treatment will be administered based on clinical diagnosis and treatment. During the surgery, excised clinical specimens will undergo incubation with TTP-ICG following this specific procedure:

1. Preparation of the incubation solution: TTP-ICG will be dissolved in phosphate-buffered saline (PBS) at room temperature in the dark, with varying concentrations (5, 10, 20 μg/mL).
2. Incubation of clinical specimens: The freshly excised clinical specimens will be immersed and gently agitated in the incubation solution for 3, 5, or 10 minutes. Subsequently, they will be rinsed with PBST buffer (PBS with Tween 20) for 5 minutes and dried using absorbent paper.
3. Acquisition of NIR-II images: NIR-II images and fluorescent intensities will be captured using the "Digital Precision Medicine (DPM)" NIR-II system, optimized with appropriate parameters.
4. Pathological diagnosis and data analysis: Hematoxylin and eosin staining, along with immuno-histochemistry, will be performed. The subsequent correlation between pathological characterization and fluorescent information will be further analyzed.

Inclusion Criteria:

• Age range: 18-75 years old;

  • Patients with oral cancer or benign oral tumors who plan to undergo surgical intervention;

    • Preoperative coagulation function test was normal; ④ No serious underlying diseases; ⑤ WHO Physical Status Score 0-2 points;

      • Sign the informed consent form;

Exclusion Criteria:

• Suffering from other invasive malignant tumors;

  • Surgery cannot be performed for other serious illnesses; ③ Suffering from mental disorders and unable to sign informed consent forms on their own;

    • The subject requests to withdraw from the clinical trial; ⑤ The researchers believe that it is not appropriate for them to continue participating in this clinical trial.