Clinical Application of FL-261 Radionuclide Imaging in the Diagnosis and Staging of Malignant Tumors
New imaging test FL-261 to detect and stage cancers
Plain English Summary
FL-261 Imaging for Cancer Diagnosis and Staging is a Not Applicable clinical trial sponsored by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology studying Non-Small Cell Lung Cancer, Colorectal Cancer, Head & Neck Cancer, Advanced Solid Tumors. This study tests a new imaging agent called FL-261 to help doctors see and stage certain cancers. It is for adults with suspected or confirmed cancers like lung, colorectal, or head and neck cancer. Participation involves undergoing a special scan (PET or SPECT) and providing existing tissue samples. Currently, cancer diagnosis often requires invasive biopsies, which can miss important information about the tumor. The trial aims to enroll 12 participants.
Official 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. 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.
Who Can Participate
Here is what you need to know about eligibility for this trial. Adults aged 18 and older can join if they have suspected or confirmed cancer. You cannot join if you are pregnant or breastfeeding, have severe illness, or cannot give consent. Good general health is required, and you must be able to follow study instructions. Investigators will decide if any other health condition makes you unsuitable. This trial is studying Non-Small Cell Lung Cancer, Colorectal Cancer, Head & Neck Cancer, Advanced Solid Tumors, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.
What They're Measuring
The primary outcome measures how well the FL-261 scan can accurately identify cancerous tumors, helping doctors understand the extent of the disease. The specific primary outcome measures are: Diagnostic Performance of [68Ga]Ga-FL-261 PET / [111In]In-FL-261 SPECT for Malignant Tumors (1 year). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.
About This Phase
This study does not have a traditional clinical phase designation. It may be an observational study that follows patients without intervening in their care, an expanded access or compassionate use program, or other non-interventional research. These studies contribute valuable data about disease progression, treatment patterns, and patient outcomes.
Why This Trial Matters
This trial matters because it explores a less invasive way to identify and understand cancer spread, potentially improving treatment decisions where current methods are limited. This research targets Non-Small Cell Lung Cancer, Colorectal Cancer, Head & Neck Cancer, Advanced Solid Tumors, where improved treatment options are needed.
Investor Insight
This trial explores a novel imaging agent targeting c-MET, a protein common in many cancers, suggesting a potential new diagnostic tool in a market seeking better cancer detection methods.
Is This Trial Right for Me?
Ask your doctor if this imaging test is right for you and how it compares to other diagnostic methods. You will need to provide informed consent and undergo imaging scans, with some tests before and after. The study will use existing tissue samples you may have had from previous procedures. This trial is currently recruiting participants. The trial is being conducted at 1 site. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.
AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.
Study Design
- Study Type: OBSERVATIONAL
- Enrollment: 12 participants
Interventions
- DIAGNOSTIC_TEST: [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
Primary Outcomes
- Diagnostic Performance of [68Ga]Ga-FL-261 PET / [111In]In-FL-261 SPECT for Malignant Tumors (1 year)
Secondary Outcomes
- Correlation With c-MET Expression and Safety of [68Ga]Ga-FL-261 / [111In]In-FL-261 (1 year)
Full Eligibility Criteria
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)
Trial Locations
- Wuhan Union Hospital, Wuhan, Hubei, China
Frequently Asked Questions
What is clinical trial NCT07510321?
NCT07510321 is a Not Applicable OBSERVATIONAL study titled "FL-261 Imaging for Cancer Diagnosis and Staging." It is currently recruiting and is sponsored by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology. The trial targets enrollment of 12 participants.
What conditions does NCT07510321 study?
This trial investigates treatments for Non-Small Cell Lung Cancer, Colorectal Cancer, Head & Neck Cancer, Advanced Solid Tumors. The primary condition under study is Non-Small Cell Lung Cancer.
What treatments are being tested in NCT07510321?
The interventions being studied include: [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
What does Not Applicable mean for NCT07510321?
This study does not have a defined clinical phase. It may be an observational study, expanded access program, or other non-interventional research.
What is the current status of NCT07510321?
This trial is currently "Recruiting." It started on 2025-11-27. The estimated completion date is 2026-12-31.
Who is sponsoring NCT07510321?
NCT07510321 is sponsored by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT07510321?
The trial aims to enroll 12 participants. The trial is currently recruiting and accepting new participants.
How is NCT07510321 designed?
This is a observational study.
What are the primary outcomes being measured in NCT07510321?
The primary outcome measures are: Diagnostic Performance of [68Ga]Ga-FL-261 PET / [111In]In-FL-261 SPECT for Malignant Tumors (1 year). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT07510321 being conducted?
This trial is being conducted at 1 site, including Wuhan, Hubei (China).
Where can I find official information about NCT07510321?
The official record for NCT07510321 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT07510321. This government database provides the most up-to-date and detailed information about the trial.
What is NCT07510321 testing in simple terms?
This study tests a new imaging agent called FL-261 to help doctors see and stage certain cancers. It is for adults with suspected or confirmed cancers like lung, colorectal, or head and neck cancer.
Why is this trial significant?
This trial matters because it explores a less invasive way to identify and understand cancer spread, potentially improving treatment decisions where current methods are limited.
What are the potential risks of participating in NCT07510321?
The main risks are related to the imaging procedure itself, which are generally low. Potential side effects are not fully known as this is a new agent, but could include reactions to the injection. As with any medical procedure, there's a small risk of infection or discomfort at the injection site. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT07510321?
Ask your doctor if this imaging test is right for you and how it compares to other diagnostic methods. You will need to provide informed consent and undergo imaging scans, with some tests before and after. The study will use existing tissue samples you may have had from previous procedures. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT07510321 signal from an investment perspective?
This trial explores a novel imaging agent targeting c-MET, a protein common in many cancers, suggesting a potential new diagnostic tool in a market seeking better cancer detection methods. This is a Not Applicable trial, which is in early development stages.
What happens if the treatment in this trial doesn't work?
Participation involves undergoing a special scan (PET or SPECT) and providing existing tissue samples. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.
Related Conditions
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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.