FL-261 Imaging for Cancer Diagnosis and Staging

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

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.

Study Overview

• Status: Recruiting
• Conditions: Colorectal Cancer; Non-Small Cell Lung Cancer; Advanced Solid Tumors; Head & Neck Cancer
• Intervention / Treatment: Diagnostic test: [68Ga]Ga-FL-261 PET Imaging / [111In]In-FL-261 SPECT Imaging

• Study Type: Observational
• Enrollment (Estimated): 12

Contacts and Locations

• Study Contact: Name: Xiaoli Lan; Phone Number: 0086-027-83692633; Email: lxl730724@hotmail.com

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430022
      • Recruiting
      • Wuhan Union Hospital
      • Contact: Xiaoli Lan; Phone Number: 0086-027-83692633; Email: lxl730724@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients with clinically suspected or histologically confirmed malignancies, including non-small cell lung cancer, colorectal cancer, and head and neck cancer, will undergo [68Ga]Ga-FL-261 PET or [111In]In-FL-261 SPECT imaging, with optional [18F]FDG PET for comparison. This study is a single-arm diagnostic study without a control group.

Description

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)

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnostic Performance of [68Ga]Ga-FL-261 PET / [111In]In-FL-261 SPECT for Malignant Tumors	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.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation With c-MET Expression and Safety of [68Ga]Ga-FL-261 / [111In]In-FL-261	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.	1 year

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): November 27, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: March 29, 2026
• First Submitted That Met QC Criteria: March 29, 2026
• First Posted (Actual): April 3, 2026

Study Record Updates

• Last Update Posted (Actual): April 3, 2026
• Last Update Submitted That Met QC Criteria: March 29, 2026
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Intestinal Diseases; Respiratory Tract Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Colonic Diseases; Lung Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Colorectal Neoplasms; Carcinoma, Non-Small-Cell Lung; Head and Neck Neoplasms
• Other Study ID Numbers: XLan-251174

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No