NCT07510321

FL-261 Imaging for Cancer Diagnosis and Staging

Clinical Application of FL-261 Radionuclide Imaging in the Diagnosis and Staging of Malignant Tumors

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 12 (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

c-MET is a receptor tyrosine kinase overexpressed in multiple malignancies and associated with tumor progression, therapeutic resistance, and poor prognosis, while showing limited expression in normal tissues, making it an attractive imaging and therapeutic target. Current assessment relies on invasive biopsy and is limited by tumor heterogeneity and sampling bias. FL-261 is a novel c-MET-targeting ligand with high affinity and specificity, favorable tumor uptake and retention, rapid background clearance, and good preclinical safety. It can be radiolabeled for both diagnostic imaging and potential theranostic applications. This first-in-human study will evaluate \[68Ga\]Ga-FL-261 PET or \[111In\]In-FL-261 SPECT imaging in patients with advanced malignancies, including non-small cell lung cancer, colorectal cancer, and head and neck cancer. The study aims to assess safety, biodistribution, and tumor-targeting capability, and to explore its diagnostic value by correlating imaging findings with histopathological c-MET expression.

Conditions

• Non-Small Cell Lung Cancer
• Colorectal Cancer
• Head & Neck Cancer
• Advanced Solid Tumors

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	[68Ga]Ga-FL-261 PET Imaging / [111In]In-FL-261 SPECT Imaging	This diagnostic study evaluates c-MET-targeted imaging using \[68Ga\]Ga-FL-261 PET or \[111In\]In-FL-261 SPECT in patients with suspected or confirmed malignancies (e.g., non-small cell lung cancer, colorectal cancer, head and neck cancer). Standard \[18F\]FDG PET may be performed for comparison. After informed consent, patients undergo FL-261 imaging, with clinical data and laboratory tests (blood, urine, ECG) collected within one week before and after imaging. Tumor diagnosis is confirmed by histopathology or follow-up. Images are independently interpreted by at least two experienced nuclear medicine physicians. Diagnostic performance, biodistribution, and tumor-targeting ability are assessed and correlated with tissue c-MET expression.

Timeline

• Start date: 2025-11-27
• Primary completion: 2026-06-30
• Completion: 2026-12-31
• First posted: 2026-04-03
• Last updated: 2026-04-03

Locations

1 site across 1 country: China