FL-261 Imaging for Cancer Diagnosis and Staging
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUnion Hospital, Tongji Medical College, Huazhong University of Science and Technology
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Inability or unwillingness to provide informed consent
Inability to comply with study procedures
Acute systemic disease or significant electrolyte imbalance
Pregnant or breastfeeding women
Trial population
Patients with clinically suspected or histologically confirmed malignancies, including non-small cell lung cancer, colorectal cancer, and head and neck cancer, will undergo \[68Ga\]Ga-FL-261 PET or \[111In\]In-FL-261 SPECT imaging, with optional \[18F\]FDG PET for comparison. This study is a single-arm diagnostic study without a control group.
Trial design
Design model
Case-only
Time perspective
Cross-sectional
Treatments tested in this trial
[68Ga]Ga-FL-261 PET Imaging / [111In]In-FL-261 SPECT Imaging
Diagnostic testThis diagnostic study evaluates c-MET-targeted imaging using \[68Ga\]Ga-FL-261 PET or \[111In\]In-FL-261 SPECT in patients with suspected or confirmed malignancies (e.g., non-small cell lung cancer, colorectal cancer, head and neck cancer). Standard \[18F\]FDG PET may be performed for comparison. After informed consent, patients undergo FL-261 imaging, with clinical data and laboratory tests (blood, urine, ECG) collected within one week before and after imaging. Tumor diagnosis is confirmed by histopathology or follow-up. Images are independently interpreted by at least two experienced nuclear medicine physicians. Diagnostic performance, biodistribution, and tumor-targeting ability are assessed and correlated with tissue c-MET expression.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Diagnostic Performance of [68Ga]Ga-FL-261 PET / [111In]In-FL-261 SPECT for Malignant Tumors
To evaluate the diagnostic accuracy of \[68Ga\]Ga-FL-261 PET or \[111In\]In-FL-261 SPECT imaging in detecting primary and metastatic lesions in patients with suspected or confirmed malignancies (e.g., non-small cell lung cancer, colorectal cancer, head and neck cancer), in comparison with \[18F\]FDG PET. Tumor presence, location, characterization, and metastasis will be assessed. Histopathology or clinical follow-up will serve as the reference standard. Diagnostic performance metrics, including sensitivity, specificity, and accuracy, will be calculated.
Time frame
1 yearSecondary outcomes
1
Correlation With c-MET Expression and Safety of [68Ga]Ga-FL-261 / [111In]In-FL-261
To assess the correlation between tracer uptake (e.g., SUV or target-to-background ratio) on FL-261 imaging and c-MET expression levels determined by immunohistochemistry in tumor tissue. Additionally, to evaluate the safety and tolerability of a single low-dose intravenous administration of \[68Ga\]Ga-FL-261 or \[111In\]In-FL-261, based on clinical observations, laboratory tests, and electrocardiogram findings.
Time frame
1 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov