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Study identifier: NCT07510321 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

FL-261 Imaging for Cancer Diagnosis and Staging

Condition: Non-Small Cell Lung Cancer · Colorectal Cancer · Head & Neck Cancer  ·  Sponsor: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

PhaseN/A
Planned participants12
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Xiaoli Lan  ·  0086-027-83692633  ·  lxl730724@hotmail.com

Always discuss trial participation with your own doctor first.

Locations (1)

Wuhan Union HospitalWuhan, Hubei, ChinaRecruiting

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Source record: clinicaltrials.gov/study/NCT07510321