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NCT Number: NCT07510321

FL-261 Imaging for Cancer Diagnosis and Staging

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.

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Key information

Conditions

Non-small Cell Lung Cancer Advanced Solid Tumors Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Colonic Diseases Colorectal Cancer Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Head & Neck Cancer Head and Neck Neoplasms Intestinal Diseases Intestinal Neoplasms Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Rectal Diseases Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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

Diagnostic Test

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.

Primary outcomes

  1. Diagnostic Performance of [68Ga]Ga-FL-261 PET / [111In]In-FL-261 SPECT for Malignant Tumors

    Time frame: 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 outcomes

  1. Correlation With c-MET Expression and Safety of [68Ga]Ga-FL-261 / [111In]In-FL-261

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Xiaoli Lan

CONTACT

[email protected]

0086-027-83692633

Sponsors and collaborators

Lead sponsor

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 3, 2026
Registry last updated
Apr 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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