About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
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.
Trial population
The investigators plan to enroll 40 female patients, aged 18 to 75 years, who have been assessed to have resectable oral cancer or oral benign tumor and are scheduled to undergo surgery. During the surgery, the resected tumors will be incubated with the TTP-ICG solution, and NIR-II fluorescence signals from the tissues will be collected.
Trial design
Case-only
Prospective
Treatments tested in this trial
TTP-ICG incubation solution
Diagnostic testFresh clinical specimens will be incubated with TTP-ICG with different concentrations and times.
Treatment groups
Trial outcomes
Primary outcomes
NIR-II fluorescence intensity of oral cancer, para-cancer tissues, and benign masses after TTP-ICG incubation
NIR-II fluorescence imaging acquisition and intensity analysis was conducted using the Digital Precision Medicine (DPM) NIR-II system. Following initial system parameter calibration and spatial scaling, fluorescence signals were captured and quantitatively analyzed to determine the ability to distinguish oral cancer from paracancerous tissues, as well as benign and malignant oral tumors.
Secondary outcomes
Expression of the Trop-2 in the oral cancer
NIR-II fluorescence intensity of the oral cancer tissues with different Trop-2 expression level after TTP-ICG incubation.
Sponsors and contacts
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