NCT07026110

Clinical Application Study of PET/CT for Differential Diagnosis of Non-small Cell Lung Cancer

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: RenJi Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This study aims to explore the efficacy of Trop2, EpCAM-specific PET/CT imaging for noninvasive visualization of Trop2 or EpCAM expression levels in non-small cell lung cancer; and to explore the differences between novel target-specific PET/CT examinations and conventional 18F-FDG PET/CT in the diagnosis and differential diagnosis of solid lung nodules.

Detailed description

A solid lung nodule was initially diagnosed as non-small cell lung cancer by chest CT. Patients with lung nodules subjected to 18F-FDG PET/CT with surgical resection/biopsy. Patients will also be included for routine follow-up, surveillance, and treatment efficacy evaluation.Enrolled patients will undergo whole-body immunoPET/CT scans 1-2 hours after tracer injection (0.05-0.1 mCi/kg). The uptake of imaging tracers in tumors and normal organs/tissues will be scored visually and quantitatively.Tumor uptake will be quantified by the maximum standard uptake value (SUVmax). The sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and accuracy will be calculated to assess the diagnostic efficacy. The correlation between lesion uptake and Trop2 and EpCAM expression level determined by immunohistochemistry staining will be further analyzed. The primary exploration endpoint will be the tracers' imaging feasibility and preliminary diagnostic value compared to conventional imaging approaches like 18F-FDG PET/CT.

Conditions

• Lung Cancer
• Lung Diseases
• Lung Neoplasms
• Lung Cancer Metastatic
• Lung Inflammation

Interventions

Type	Name	Description
DRUG	[68Ga]Ga-NOTA-T4	Enrolled patients will receive 0.05-0.1 mCi/kg of \[68Ga\]Ga-NOTA-T4. ImmunoPET/CT imaging will be acquired 1-2 hours after \[68Ga\]Ga-NOTA-T4 injection.
DRUG	[68Ga]Ga-NOTA-RT4	Enrolled patients will receive 0.05-0.1 mCi/kg of \[68Ga\]Ga-NOTA-RT4. ImmunoPET/CT imaging will be acquired 1-2 hours after \[68Ga\]Ga-NOTA-RT4 injection.
DRUG	[18F]F-RESCA-T4	Enrolled patients will receive 0.05-0.1 mCi/kg of \[18F\]F-RESCA-T4. ImmunoPET/CT imaging will be acquired 1-2 hours after \[18F\]F-RESCA-T4 injection.
DRUG	[18F]F-RESCA-RT4	Enrolled patients will receive 0.05-0.1 mCi/kg of \[18F\]F-RESCA-RT4. ImmunoPET/CT imaging will be acquired 1-2 hours after \[18F\]F-RESCA-RT4 injection.
DRUG	[18F]F-RESCA-EPCD6	Enrolled patients will receive 0.05-0.1 mCi/kg of \[18F\]F-RESCA-EPCD6. ImmunoPET/CT imaging will be acquired 1-2 hours after \[18F\]F-RESCA-EPCD6 injection.
DRUG	[68Ga]Ga-NOTA-EPCD6	Enrolled patients will receive 0.05-0.1 mCi/kg of \[68Ga\]Ga-NOTA-EPCD6. ImmunoPET/CT imaging will be acquired 1-2 hours after \[68Ga\]Ga-NOTA-EPCD6 injection.

Timeline

• Start date: 2024-12-23
• Primary completion: 2026-10-31
• Completion: 2026-10-31
• First posted: 2025-06-18
• Last updated: 2025-06-18

Locations

1 site across 1 country: China