An observational study in Oral Squamous Cell Carcinoma (OSCC) and Diagnosis, sponsored by Yunnan Cancer Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-08-31.
Sponsored by Yunnan Cancer Hospital · Observational
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:
2,018 studies on the registry are indexed under Squamous Cell Carcinoma of Head and Neck; 573 are open to participants now.
This study's planned enrollment of 40 is below the median of 100 across 236 observational studies indexed under Squamous Cell Carcinoma of Head and Neck.
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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.
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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;
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 forms on their own;
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The fresh excision clinical specimens will be completely soaked in the TTP-ICG incubation solution (5, 10, 20 μg/mL) for 3, 5, or 10 min, followed by 5 min of rinsing with PBST buffer and drying with absorbent paper. The NIR-II fluorescence imaging will be then performed under the DPM NIR-II system. And the correlation between pathological characterization and fluorescent information will be further analyzed
Diagnostic Test: TTP-ICG incubation solution
Fresh clinical specimens will be incubated with TTP-ICG with different concentrations and times.
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.
Time frame: 1 year
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.
Time frame: 1 year
Plan to share: No
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