Clinical trial · Observational
FL-261 Imaging for Cancer Diagnosis and Staging
Clinical Application of FL-261 Radionuclide Imaging in the Diagnosis and Staging of Malignant Tumors
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Head & Neck Cancer | — | UNRESOLVED | — |
| Non-Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| [68Ga]Ga-FL-261 PET Imaging / [111In]In-FL-261 SPECT Imaging | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Diagnostic Performance of [68Ga]Ga-FL-261 PET / [111In]In-FL-261 SPECT for Malignant Tumors
- timeFrame
- 1 year
- description
- 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)
- measure
- Correlation With c-MET Expression and Safety of [68Ga]Ga-FL-261 / [111In]In-FL-261
- timeFrame
- 1 year
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (0)
Data not yet available