Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07794813

Trop2-targeting 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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Yunnan Cancer Hospital

Kunming, Yunnan, 650118, China

Location status: Recruiting

Location contact

Chuanzheng Sun, Doctor

PRINCIPAL_INVESTIGATOR

Guojun Zhang Zhang, Doctor

PRINCIPAL_INVESTIGATOR

Guojun Zhang doctor

CONTACT

[email protected]

86+18850064298

Jingwen Bai,Doctor

PRINCIPAL_INVESTIGATOR

Tao Xie

PRINCIPAL_INVESTIGATOR

Yixin Chen

CONTACT

[email protected]

+86 18305902616

Yixin Chen

PRINCIPAL_INVESTIGATOR

About this study

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:

  • 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).
  • 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.
  • 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.
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

TTP-ICG incubation solution

Diagnostic Test

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

Primary outcomes

  1. NIR-II fluorescence intensity of oral cancer, para-cancer tissues, and benign masses after TTP-ICG incubation

    Time frame: 1 year

    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

  1. Expression of the Trop-2 in the oral cancer

    Time frame: 1 year

    NIR-II fluorescence intensity of the oral cancer tissues with different Trop-2 expression level after TTP-ICG incubation.

Study contacts

Contact information is provided by the study sponsor or research team.

Jingwen Bai,Doctor, doctor

CONTACT

[email protected]

86+13411961052

Yixin Chen, postgraduate

CONTACT

[email protected]

86+ 18305902616

Sponsors and collaborators

Lead sponsor

Yunnan Cancer Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Aug 31, 2026
Registry last updated
Aug 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.