FL-261 scans to find and stage advanced cancers, including lung and colorectal
Tests FL-261 imaging in adults with advanced lung, colorectal, and head and neck cancers.
Key facts
- Who runs it
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
- Where
- Wuhan, ChinaSee the site
- Trial code
- Registry title
- FL-261 Imaging for Cancer Diagnosis and Staging
- Status
- Recruiting
- People taking part
- 12 people, planned
- Started
- 27 Nov 2025
- Expected to end
- 31 Dec 2026
- Type of study
- Observational
- Treatments tested
- [68Ga]Ga-FL-261 PET Imaging / [111In]In-FL-261 SPECT Imaging
- Record updated
- 3 April 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with suspected or confirmed cancer, such as lung, colorectal, or head and neck cancer, to test a new scan called FL-261 imaging.
- Age
- 18 years or older
- Sex
- All sexes can join
- Disease stage
- Cancer that is suspected or confirmed by biopsy, supported by tumor markers, scans (ultrasound, CT, MRI), or pathology. Examples: non-small cell lung cancer, colorectal cancer, head and neck cancer.
Main reasons for not taking part
- Cannot give informed consent
- Cannot follow the study procedures
- Sudden (acute) whole-body illness or a significant electrolyte imbalance
- Pregnant or breastfeeding women
- Any condition the investigator considers unsuitable, for example known intolerance to c-MET-targeted agents
The registry criteria, word for word
Show all 11 criteriaShow less
Who can take part
- 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
Who cannot take part
- Acute systemic disease or significant electrolyte imbalance
- Any condition deemed unsuitable by the investigator (e.g., known intolerance to c-MET-targeted agents)
- Inability or unwillingness to provide informed consent
- Inability to comply with study procedures
- Pregnant or breastfeeding women
Where in China
- Wuhan Union HospitalWuhan, ChinaContact: Xiaoli LanTaking people
About the trial
What the trial wants to find out
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.
Read full original descriptionShow less
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.
Treatments tested
- [68Ga]Ga-FL-261 PET Imaging / [111In]In-FL-261 SPECT Imaging
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Clinical Application of FL-261 Radionuclide Imaging in the Diagnosis and Staging of Malignant Tumors
- Plain-language title
- FL-261 scans to find and stage advanced cancers, including lung and colorectalGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 13 November 2026.
- Record updated
- 3 April 2026