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Effect of Fluorescence Visualization-Guided Biopsy Oral Squamous Cell Carcinoma

Effect of Fluorescence Visualization-Guided Biopsy Oral Squamous Cell Carcinoma

Status
Recruiting
Phases
Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2300074454
Enrollment
Unknown
Registered
2023-08-07
Start date
2023-03-01
Completion date
Unknown
Last updated
2023-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Oral squamous cell carcinoma

Interventions

Gold Standard:Positive biopsy pathological results were the gold standard
Index test:To evaluate the diagnostic efficacy of MET-targeted fluorescent probe combined with real-time near-infrared fluorescence imaging for early oral cancer and precancerous lesions

Sponsors

Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: Patients with potential malignant diseases of the oral mucosa (OPMDS) (including leukoplakia, oral lichen planus, oral submucosal fibrosis, discogenic lupus erythematosus, and others), aged over 18 years, with planned biopsy, expected survival greater than 12 weeks, KPS score greater than 70%, or ECOG score of f0 or 1, and hemoglobin concentration =9mg /dL; The platelet count was more than 100 000 cells per ratio, and the concentration of magnesium, potassium and calcium was normal. The subjects voluntarily participated in the clinical trial and signed the informed consent.

Exclusion criteria

Exclusion criteria: History of oral cancer, participation in relevant clinical trials within 30 days, ICG allergy, myocardial infarction, cerebrovascular accident, uncontrolled congestive heart failure, or unstable angina within 6 months, pregnancy or lactation, and use of class 1A or 3 antiarrhythmic drugs.

Design outcomes

Primary

MeasureTime frame
the accuracy of fluorescence imaging of oral lesions by applying mesenchymal epithelial transformation factor (MET) targeted probes on the surface of oral lesions before surgery;

Countries

China

Contacts

Public ContactTao Xiaofeng

Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

cjr.taoxiaofeng@vip.163.com+86 138 0166 6309

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 5, 2026