TheranosticTrials.org

Clinical Trial · NCT06690216

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

Overview

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.

Sponsor

Peking University Cancer Hospital & Institute

Phase

Phase 1/2

Contacts

Man Hu, Dr. (STUDY_CHAIR)

ClinicalTrials.gov

NCT06690216

Drug / Compound

AlF-NOTA-PCP2

Isotope(s):
Target(s):
  • PD-L1
Ligand Class: Peptides
Chelator: NOTA

Eligibility

Inclusion

  • Detectable PD-L1 expression in tumor tissue (based on immunohistochemistry or biopsy).
  • Willing and able to comply with study procedures and follow-up visits.
  • No contraindications to \[18F\]AlF-NOTA-PCP2 PET/CT imaging.
  • Measurable disease with at least one residual tumor lesion.
  • Non-small cell lung cancer
  • ECOG performance status of 0-1.
  • Esophageal cancer
  • Pathologically confirmed malignant tumors, including:

Exclusion

  • Women of childbearing potential without a negative pregnancy test prior to study entry.
  • Any medical history, laboratory abnormality, or condition that may:
  • Pregnant or breastfeeding women.
  • Affect patient participation.
  • Known allergy or hypersensitivity to \[18F\]AlF-NOTA-PCP2 or any component of the radiopharmaceutical.
  • Major, symptomatic arrhythmias or significant ECG abnormalities (e.g., complete left bundle branch block, second-degree or higher heart block, or ventricular arrhythmias).
  • Severe psychiatric disorders affecting study participation.
  • Participation in another interventional clinical trial.
  • Active or uncontrolled infections requiring systemic treatment.
  • Pose an unacceptable risk as determined by the investigator.
  • Unstable angina or congestive heart failure (NYHA class ≥ 2).
  • Interfere with study results.
  • Severe or uncontrolled systemic diseases, including:
  • Failure to recover from toxic effects or complications of prior interventions (≤ grade 1 or baseline levels, excluding fatigue or hair loss).
  • Any arterial thrombotic or embolic events within 6 months before enrollment (e.g., myocardial infarction, cerebrovascular accident, transient ischemic attack).