Evaluation of [18F]AlF-NOTA-PCP2 PET/CT for PD-L1 Detection in Malignant Tumors

NCT06690216 · tracked via the Priya Life Science China tracker

Sponsor

Man Hu

Phase

Phase 1/2

Started

2024-03-30

Last updated

2025-03-30

Condition(s) studied

Glioblastoma (GBM)Head and Neck Squamous Cell CarcinomaNon-Small Cell Lung CancerEsophageal Cancer

Investigational drug(s) / intervention(s)

PET/CT （[18F]AlF-NOTA-PCP2）[18F]AlF-NOTA-PCP2 PET/CT Imaging for PD-L1 Expression in Malignant Tumors

PET/CT （[18F]AlF-NOTA-PCP2）: This intervention involves the use of \[18F\]AlF-NOTA-PCP2, a radiopharmaceutical agent specifically designed for PET/CT imaging. Patients will receive an intravenous injection of \[18F\]AlF-NOTA-PCP2, followed by whole-body PET/CT scanning one hour later. The primary purpose of this intervention is to assess PD-L1 expression in malignant tumors, including glioblastoma, head and neck squamous cell carcinoma, non-small cell lung cancer, and esophageal cancer, before the initiation of treatment. This imaging technique offers a non-invasive, repeatable, and comprehensive method to monitor PD-L1 status, in contrast to traditional tissue biopsy, which is invasive and limited to a single time point.

[18F]AlF-NOTA-PCP2 PET/CT Imaging for PD-L1 Expression in Malignant Tumors: This intervention involves the use of \[18F\]AlF-NOTA-PCP2, a radiopharmaceutical agent specifically designed for PET/CT imaging. Patients will receive an intravenous injection of \[18F\]AlF-NOTA-PCP2, followed by whole-body PET/CT scanning one hour later. The primary purpose of this intervention is to assess PD-L1 expression in malignant tumors, including glioblastoma, head and neck squamous cell carcinoma, non-small cell lung cancer, and esophageal cancer, before the initiation of treatment. This imaging technique offers a non-invasive, repeatable, and comprehensive method to monitor PD-L1 status, in contrast to traditional tissue biopsy, which is invasive and limited to a single time point.

Study summary

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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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.

Primary outcome measure(s)

Assessment of [18F]AlF-NOTA-PCP2 PET/CT imaging for PD-L1 expression in malignant tumors — Pre-treatment imaging, within 1-7 days before treatment initiation.
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).

Trial sites (1)

Facility	City	Region	Status
Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Sciences	Jinan	Shandong

More Man Hu trials in China

Phase III Non-Inferiority Trial of Proton Versus Photon Therapy for Nasopharyngeal Carcinoma Recruiting

Proton vs Photon IMRT in Locally Advanced Nasopharyngeal Carcinoma: A Phase III Trial Recruiting

Other trials for the same condition

Third-generation EGFR-TKI Plus Anlotinib as Maintenance for NSCLC With Small Cell Transformation After EGFR-TKI Resistance Starting soon

Radiation Therapy Followed by Tislelizumab and Anlotinib Aeoadjuvant/Adjuvant Therapy for Stage II-IIIA NSCLC Recruiting

A Study of BL-B01D1+PD-1 Monoclonal Antibody in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer, Nasopharyngeal Carcinoma and Other Solid Tumors Recruiting

A Study of BL-B01D1 in Combination With Osimertinib Mesylate Tablets in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer Recruiting

Consolidation Radiotherapy vs. Observation in Oligoresidual Advanced Non-Small Cell Lung Cancer After Chemo-Immunotherapy Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06690216 on ClinicalTrials.gov ↗ ← All trials in China