FL-261 Imaging for Cancer Diagnosis and Staging

Официальное название

Clinical Application of FL-261 Radionuclide Imaging in the Diagnosis and Staging of Malignant Tumors

Обзор

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.

Вмешательства

• Диагностический тест [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

Первичные конечные точки

• Diagnostic Performance of [68Ga]Ga-FL-261 PET / [111In]In-FL-261 SPECT for Malignant Tumors [Срок оценки: 1 year]

Вторичные конечные точки (1)

• Correlation With c-MET Expression and Safety of [68Ga]Ga-FL-261 / [111In]In-FL-261 [Срок оценки: 1 year]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Только случаи

Центры проведения

Китай · 1 центр

• Wuhan Union Hospital — Ухань

Идентификаторы

NCT: NCT07510321 · XLan-251174

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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