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

NCT07794813 | Recruiting DMC

• 1 other identifier: KYLX2024-315
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Oral Squamous Cell Carcinoma (OSCC); Diagnosis

Keywords

oral suqaremous cell cancer; diagnosis; trop2; NIR-II

Outcome Measures

Primary Outcomes (1)

• 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.

  1 year

Secondary Outcomes (1)

• Expression of the Trop-2 in the oral cancer

  1 year

Study Arms (1)

TTP-ICG incubation

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

Interventions

TTP-ICG incubation solution DIAGNOSTIC_TEST

Fresh clinical specimens will be incubated with TTP-ICG with different concentrations and times.

TTP-ICG incubation

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study 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.

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yunnan Cancer Hospital: lead

Study Sites (1)

Yunnan Cancer Hospital

Kunming, Yunnan, 650118, China

RECRUITING

Related Publications (1)

• Chen W, Zhang Y, Zhang L, Luo X, Yang X, Zhu Y, Wang G, Huang W, Zhang D, Zeng Y, Li R, Guo C, Wang J, Wu Z, Liu N, Zhang G. Intraoperative evaluation of tumor margins using a TROP2 near-infrared imaging probe to enable human breast-conserving surgery. Sci Transl Med. 2024 Oct 16;16(769):eado2461. doi: 10.1126/scitranslmed.ado2461. Epub 2024 Oct 16.

  PMID: 39413161 RESULT

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck; Disease

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Yixin Chen, postgraduate

CONTACT

86+ 18305902616; 844907195@qq.com

Jingwen Bai，Doctor, doctor

CONTACT

86+13411961052; baijingwen666@126.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2026
• First Posted: August 31, 2026
• Study Start: December 3, 2024
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): January 30, 2027
• Last Updated: August 31, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)