FL-261 Imaging for Cancer Diagnosis and Staging
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: [68Ga]Ga-FL-261 PET Imaging / [111In]In-FL-261 SPECT Imaging.
- Who it may be relevant to
- Registry conditions: Non-Small Cell Lung Cancer, Colorectal Cancer, Head & Neck Cancer, Advanced Solid Tumors. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Clinical Application of FL-261 Radionuclide Imaging in the Diagnosis and Staging of Malignant Tumors
Overview
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
Primary outcome measures
- Diagnostic Performance of [68Ga]Ga-FL-261 PET / [111In]In-FL-261 SPECT for Malignant Tumors [Time frame: 1 year]
Secondary outcome measures (1)
- Correlation With c-MET Expression and Safety of [68Ga]Ga-FL-261 / [111In]In-FL-261 [Time frame: 1 year]
Eligibility 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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
China · 1 center
- Wuhan Union Hospital — Wuhan
Identifiers
NCT: NCT07510321 · XLan-251174