Clinical trial · Interventional
Evaluation of [18F]AlF-NOTA-PCP2 PET/CT for PD-L1 Detection in Malignant Tumors
Evaluation of the Value of [18F]AlF-NOTA-PCP2 PET/CT for PD-L1 Detection in 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)
This phase I/II clinical trial evaluates the safety, efficacy, and prognostic potential of \[18F\]AlF-NOTA-PCP2 PET/CT imaging in assessing PD-L1 expression in malignant tumors, including glioblastoma, head and neck squamous cell carcinoma, non-small cell lung cancer, and esophageal cancer. The primary aim is to establish the correlation between \[18F\]AlF-NOTA-PCP2 uptake and PD-L1 expression in tumor tissues, while secondary objectives include evaluating its role in predicting clinical outcomes such as progression-free survival (PFS) and overall survival (OS). By providing a non-invasive, quantitative, and reproducible method for assessing PD-L1, this study aims to refine patient stratification and improve the precision of immunotherapy decision-making.
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 |
|---|---|---|---|
| Esophageal Cancer | Malignant Esophageal Neoplasm | CURATED_EXACT | 0.92 |
| Glioblastoma (GBM) | Glioblastoma | CURATED_BROADER | 0.80 |
| Head and Neck Squamous Cell Carcinoma | Head and Neck Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Non-Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| [18F]AlF-NOTA-PCP2 PET/CT Imaging for PD-L1 Expression in Malignant Tumors | Diagnostic Test | — | UNRESOLVED |
| PET/CT ([18F]AlF-NOTA-PCP2) | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- [18F]AlF-NOTA-PCP2 PET/CT Imaging for PD-L1 Expression in Malignant Tumors
- description
- This arm involves the administration of \[18F\]AlF-NOTA-PCP2 via intravenous injection followed by whole-body PET/CT imaging one hour later. The objective is to assess the uptake of \[18F\]AlF-NOTA-PCP2 in malignant tumors and correlate it with PD-L1 expression. This imaging technique is used to evaluate PD-L1 expression in glioblastoma, head and neck squamous cell carcinoma, non-small cell lung cancer, and esophageal cancer patients before treatment, providing a non-invasive, repeatable, and comprehensive approach to guide immunotherapy decisions.
- interventionNames
- Diagnostic Test: PET/CT ([18F]AlF-NOTA-PCP2)
- Diagnostic Test: [18F]AlF-NOTA-PCP2 PET/CT Imaging for PD-L1 Expression in Malignant Tumors
Primary outcomes (1)
- measure
- Assessment of [18F]AlF-NOTA-PCP2 PET/CT imaging for PD-L1 expression in malignant tumors
- timeFrame
- Pre-treatment imaging, within 1-7 days before treatment initiation.
- description
- This outcome measure will assess the safety and efficacy of \[18F\]AlF-NOTA-PCP2 PET/CT in detecting PD-L1 expression in malignant tumors (glioblastoma, head and neck squamous cell carcinoma, non-small cell lung cancer, and esophageal cancer). This will include evaluating the correlation between \[18F\]AlF-NOTA-PCP2 uptake and PD-L1 expression as determined by immunohistochemistry (IHC).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Signed informed consent obtained. * Age ≥ 18 years, any gender. * Pathologically confirmed malignant tumors, including: * Glioblastoma * Head and neck squamous cell carcinoma * Non-small cell lung cancer * Esophageal cancer * Detectable PD-L1 expression in tumor tissue (based on immunohistochemistry or biopsy). * Measurable disease with at least one residual tumor lesion. * ECOG performance status of 0-1. * No contraindications to \[18F\]AlF-NOTA-PCP2 PET/CT imaging. * Willing and able to comply with study procedures and follow-up visits. Exclusion Criteria: * Participation in another interventional clinical trial. * Failure to recover from toxic effects or complications of prior interventions (≤ grade 1 or baseline levels, excluding fatigue or hair loss). * Pregnant or breastfeeding women. * Severe or uncontrolled systemic diseases, including: * Major, symptomatic arrhythmias or significant ECG abnormalities (e.g., complete left bundle branch block, second-degree or higher heart block, or ventricular arrhythmias). * Unstable angina or congestive heart failure (NYHA class ≥ 2). * Any arterial thrombotic or embolic events within 6 months before enrollment (e.g., myocardial infarction, cerebrovascular accident, transient ischemic attack). * Active or uncontrolled infections requiring systemic treatment. * Severe psychiatric disorders affecting study participation. * Any medical history, laboratory abnormality, or condition that may: * Interfere with study results. * Affect patient participation. * Pose an unacceptable risk as determined by the investigator. * Women of childbearing potential without a negative pregnancy test prior to study entry. * Known allergy or hypersensitivity to \[18F\]AlF-NOTA-PCP2 or any component of the radiopharmaceutical.
References
Publications (2)
- RESULTWang Y, Zhang Y, Chen Y, Wang S, Liu W, Liu Z, Hu M. [18F]AlF-NOTA-PCP2: a novel PET/CT tracer for enhanced PD-L1 heterogeneity imaging and comparative analysis with [18F]AlF-NOTA-WL12 in glioblastoma xenografts. Eur J Nucl Med Mol Imaging. 2024 Sep;51(11):3161-3175. doi: 10.1007/s00259-024-06743-5. Epub 2024 May 7. PMID 38713298
- RESULTZhang Y, Wang Y, Chen Y, Ding X, Wang S, Liu W, Hu M, Liu Z. PET Imaging of Peptide Probe Al[18F]F-NOTA-PCP1 for Monitoring the Engagement of PD-L1 Antibodies in Tumors. Mol Pharm. 2024 Mar 4;21(3):1515-1525. doi: 10.1021/acs.molpharmaceut.3c01151. Epub 2024 Jan 30. PMID 38291578