Actively Recruiting
FL-261 Imaging for Cancer Diagnosis and Staging
Led by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Updated on 2026-04-03
12
Participants Needed
1
Research Sites
57 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
FL-261 Imaging for Cancer Diagnosis and Staging
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ability to provide written informed consent (by the subject or legally authorized representative)
- Willingness and ability to comply with all study procedures
- Age 2518 years, any sex
- Clinically suspected or histologically confirmed malignancies (e.g., non-small cell lung cancer, colorectal cancer, head and neck cancer), supported by tumor markers, imaging (ultrasound, CT, MRI), or pathology
- Good general condition
- Agreement to use existing tissue samples
You will not qualify if you...
- Inability or unwillingness to provide informed consent
- Inability to comply with study procedures
- Acute systemic disease or significant electrolyte imbalance
- Pregnant or breastfeeding women
- Any condition deemed unsuitable by the investigator (e.g., known intolerance to c-MET-targeted agents)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Wuhan Union Hospital
Wuhan, Hubei, China, 430022
Actively Recruiting
Research Team
X
Xiaoli Lan
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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