Actively Recruiting
Clinical Application of FL-261 Radionuclide Imaging in the Diagnosis and Staging of Malignant Tumors
Led by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Updated on 2026-04-03
12
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a new imaging agent called FL-261, which targets a protein called c-MET that is often found in higher amounts in several cancers such as non-small cell lung cancer, colorectal cancer, and head and neck cancer. This protein is linked to tumor growth and resistance to treatment. The study aims to assess the safety, how the agent spreads in the body, and its ability to detect tumors. It also compares imaging results to the presence of c-MET in tissue samples to explore its diagnostic value. Participants will undergo diagnostic imaging using either [68Ga]Ga-FL-261 PET or [111In]In-FL-261 SPECT scans. These imaging methods aim to highlight tumors by targeting c-MET. Some patients may also have standard [18F]FDG PET scans for comparison. The study involves collecting clinical data and lab tests such as blood, urine, and ECG within a week before and after imaging. Tumor confirmation is done by tissue analysis or ongoing follow-up. During the study, images will be reviewed independently by nuclear medicine experts to evaluate diagnostic accuracy and tumor targeting. Participants' general health and safety will be monitored throughout. Researchers will measure the diagnostic performance of the imaging agents over one year and assess their correlation with c-MET expression in tumor tissues. The study does not involve treatment but focuses on improving cancer diagnosis and staging.
CONDITIONS
Brief 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 6518 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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 week
Participants undergo FL-261 radionuclide imaging and standard imaging tests. Clinical data and laboratory tests are collected before and after imaging to assist in diagnosis and staging of malignant tumors.
1 imaging visit and 2 laboratory test visits (in-person)
Duration - 1 year
Participants are monitored for diagnostic performance and correlation with tissue c-MET expression over a 1-year period following imaging.
Follow-up assessments as needed
Trial Site Locations
Total: 1 location
1
Wuhan Union Hospital
Wuhan, Hubei, China, 430022
Actively Recruiting
Research Team
X
Xiaoli Lan
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
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here