FL-261 imaging to detect and stage c-MET–expressing cancers
Official title: Clinical Application of FL-261 Radionuclide Imaging in the Diagnosis and Staging of Malignant Tumors
Run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · NCT07510321 · Data updated 2026-11-12
This first-in-human test uses FL-261 labeled for PET or SPECT to see if it safely highlights c-MET–positive tumors in adults with advanced solid tumors such as non-small cell lung, colorectal, or head and neck cancer.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 12 (estimated) |
| Sponsor | Union Hospital, Tongji Medical College, Huazhong University of Science and Technology Academic / other |
| Locations | 1 site (Wuhan, Hubei) |
| Status | Recruiting |
| Started | November 27, 2025 |
| Main results expected | June 30, 2026 |
| Study ends | December 31, 2026 |
| Registry record updated | April 3, 2026 |
| Trial ID | NCT07510321 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18 or older with clinically suspected or histologically confirmed advanced non-small cell lung cancer, colorectal cancer, head and neck cancer, or other solid tumors who can give informed consent and comply with study procedures are eligible.
✕Probably not a fit
Pregnant or breastfeeding individuals, patients with acute systemic illness or significant electrolyte imbalance, those unable to comply with procedures, or tumors that do not express c-MET are unlikely to benefit from this imaging agent.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
FL-261 is a novel ligand that targets the c-MET receptor and can be radiolabeled with 68Ga for PET or 111In for SPECT imaging. This observational, first-in-human imaging study will administer the radiolabeled agent to adults with suspected or histologically confirmed advanced malignancies and monitor safety, whole-body biodistribution, and tumor uptake. Imaging findings will be correlated with available pathology, tumor markers, and prior imaging to explore diagnostic value and tumor-targeting specificity. Participants must be able to consent, comply with procedures, and agree to use of existing tissue samples; scans are performed at a single site in Wuhan, China.
Why it matters
Potential benefit: If successful, FL-261 imaging could provide a noninvasive way to identify and stage c-MET–expressing tumors and help select patients for targeted or theranostic approaches.
How similar studies have gone: Other c-MET–targeted imaging agents have shown promising results in preclinical studies and early-phase work, but FL-261 represents a novel first-in-human agent and its clinical performance is not yet proven.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Ability to provide written informed consent (by the subject or legally authorized representative) * Willingness and ability to comply with all study procedures * Age ≥18 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 Exclusion Criteria: * 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)
Where it's running
-
Wuhan Union Hospital
Wuhan, Hubei, China Recruiting
Study contacts
- Study coordinator: Xiaoli Lan
- Email: lxl730724@hotmail.com
- Phone: 0086-027-83692633
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.