Advanced Solid Tumors, Colorectal Cancer, Head & Neck Cancer, Non-Small Cell Lung Cancer
Conditions
Brief summary
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.
Interventions
DIAGNOSTIC_TEST[68Ga]Ga-FL-261 PET Imaging / [111In]In-FL-261 SPECT Imaging
This 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.
Sponsors
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Study design
Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic Performance of [68Ga]Ga-FL-261 PET / [111In]In-FL-261 SPECT for Malignant Tumors | 1 year | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Correlation With c-MET Expression and Safety of [68Ga]Ga-FL-261 / [111In]In-FL-261 | 1 year | 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. |
Countries
China
Contacts
CONTACTXiaoli Lan
Outcome results
None listed