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

NCT07794813 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 40

Last updated 2026-08-31

No results posted yet for this study

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

Interventions

DIAGNOSTIC_TEST

TTP-ICG incubation solution

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

Sponsors & Collaborators

  • Yunnan Cancer Hospital

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-03
Primary Completion
2026-12-30
Completion
2027-01-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07794813 on ClinicalTrials.gov