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โ† Trials
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FL-261 Imaging for Cancer Diagnosis and Staging

Recruitingn/aAges 18 Years - anyAllUnion Hospital, Tongji Medical College, Huazhong โ€ฆ
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In plain words

What the trial is, and whether it could suit you

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, biodistributi

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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 โ‰ฅ18 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)
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What it tests

  • [68Ga]Ga-FL-261 PET Imaging / [111In]In-FL-261 SPECT Imaging
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Where

1 site
Wuhan Union Hospital
Wuhan, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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