NCT07510321Recruiting
FL-261 Imaging for Cancer Diagnosis and Staging
Clinical Application of FL-261 Radionuclide Imaging in the Diagnosis and Staging of Malignant Tumors
Source: ClinicalTrials.gov · Last updated 3 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 12 (estimated)
- First submitted
- 29 Mar 2026
- Start date
- 27 Nov 2025
- Primary completion date
- 30 Jun 2026
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
- Diseases
- Head and neck cancer, Lung cancer, Colorectal cancer
- NCT number
- NCT07510321
What you commit to
- Study type: Observational
- Planned participants: 12
- From 27 Nov 2025 to the primary completion date, 30 Jun 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Acute systemic disease or significant electrolyte imbalance
- Any condition deemed unsuitable by the investigator (e.g., known intolerance to c-MET-targeted agents)
Other
- Inability or unwillingness to provide informed consent
- Inability to comply with study procedures
- Pregnant or breastfeeding women
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Wuhan Union Hospital Coordinator of this site? Confirm its status | Wuhan | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.