Non-Small Cell Lung CancerNCT07510321
FL-261 Imaging for Cancer Diagnosis and Staging
An observational study of Non-Small Cell Lung Cancer and Colorectal Cancer, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Small Cell Lung Cancer, Colorectal Cancer, Head & Neck Cancer
- What is being tested?
- [68Ga]Ga-FL-261 PET Imaging / [111In]In-FL-261 SPECT Imaging
- How many people
- 12 participants
- Where
- 1 siteChina
- Study dates
- 27 Nov 2025to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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 join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Wuhan Union Hospital
Wuhan, Hubei, 430022
Xiaoli Lan, 0086-027-83692633, lxl730724@hotmail.com
About this study
Official title: 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.
- Being tested
- [68Ga]Ga-FL-261 PET Imaging / [111In]In-FL-261 SPECT Imaging
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Colorectal Neoplasms, Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[68Ga]Ga-FL-261 PET Imaging / [111In]In-FL-261 SPECT ImagingDiagnostic 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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Secondary outcomes (1)
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2026
- Study start27 Nov 2025
- Primary completion30 Jun 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07510321
- Sponsor's protocol ID
- XLan-251174
- Status last verified
- Nov 2025
- First submitted
- 29 Mar 2026
- Last updated
- 3 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Application of FL-261 Radionuclide Imaging in the Diagnosis and Staging of Malignant Tumors
- ClinicalTrials.gov ID
- NCT07510321
- Acronym / sponsor ID
- XLan-251174
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- 27 Nov 2025 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 3 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| [68Ga]Ga-FL-261 PET Imaging / [111In]In-FL-261 SPECT ImagingThis 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. | Diagnostic test | – |
Primary outcome
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.
1 secondary outcome
Correlation With c-MET Expression and Safety of [68Ga]Ga-FL-261 / [111In]In-FL-261
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-Small Cell Lung Cancer and Colorectal Cancer, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiaoli Lan (0086-027-83692633, lxl730724@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic Performance of [68Ga]Ga-FL-261 PET / [111In]In-FL-261 SPECT for Malignant Tumors (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2026.