NCT07301801

Clinical Application of 68Ga-FL-031 PET in the Diagnosis and Staging of Malignant Tumors

• Status: Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The project's objective is to recruit patients with clinically confirmed or suspected small cell lung cancer, breast cancer, nasopharyngeal carcinoma and other tumours for 68Ga-FL-031 PET imaging and 18F-FDG PET imaging. The histopathology of biopsy or surgical specimens was taken as the final diagnostic criteria, and the presence or absence of tumour lesions was confirmed by the aforementioned imaging. The location and nature of the lesion, and the presence or absence of metastasis, were then judged. The objective was to analyse and clarify the diagnostic efficacy of 68Ga-FL-031 PET imaging for the aforementioned malignant tumours. The objective of this study is to analyse the correlation between the 68Ga-FL-031 PET imaging tumour tissue uptake value and the tumour tissue immunohistochemical staining SSTR2 target expression.

Conditions

• Malignant Tumors
• SSTR2
• PET

Interventions

Type	Name	Description
DRUG	Injection of 68Ga-FL-031	Patients will be injected with 68Ga-FL-031and PET imaging was performed at different time points
DRUG	Injection of 18F-FDG	Patients will be injected with 18F-FDG and PET imaging was performed

Timeline

• Start date: 2025-06-12
• Primary completion: 2026-09-01
• Completion: 2026-09-30
• First posted: 2025-12-24
• Last updated: 2025-12-24

Locations

1 site across 1 country: China