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

NCT06690216 | Enrolling By Invitation Phase 1

• 2 other identifiers: ShandongCHI202410074KY-2024-136
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Glioblastoma (GBM); Head and Neck Squamous Cell Carcinoma; Non-Small Cell Lung Cancer; Esophageal Cancer

Keywords

PET/CT; PD-L1 expression; [18F]AlF-NOTA-PCP2; Glioblastoma; Head and neck squamous cell carcinoma; Non-small cell lung cancer; Esophageal cancer; Immunotherapy guidance; Tumor biomarker imaging

Outcome Measures

Primary Outcomes (1)

• Assessment of [18F]AlF-NOTA-PCP2 PET/CT imaging for PD-L1 expression in malignant tumors

  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).

  Pre-treatment imaging, within 1-7 days before treatment initiation.

Secondary Outcomes (1)

• [18F]AlF-NOTA-PCP2 PET/CT imaging as a prognostic biomarker in malignant tumors

  Up to 1 year of follow-up for clinical outcomes (PFS, OS).

Other Outcomes (1)

• Correlation of circulating PD-L1 and exosomal PD-L1 with [18F]AlF-NOTA-PCP2 PET/CT imaging

  Pre-treatment, and at follow-up visits (up to 1 year).

Study Arms (1)

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

EXPERIMENTAL

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.

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

Interventions

PET/CT （[18F]AlF-NOTA-PCP2） DIAGNOSTIC_TEST

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

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

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Man Hu: lead

Study Sites (1)

Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Sciences

Jinan, Shandong, 250117, China

Location

Related Publications (2)

• Wang 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 BACKGROUND

• Zhang 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 BACKGROUND

MeSH Terms

Conditions

Glioblastoma; Squamous Cell Carcinoma of Head and Neck; Carcinoma, Non-Small-Cell Lung; Esophageal Neoplasms

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Carcinoma, Squamous Cell; Carcinoma; Head and Neck Neoplasms; Neoplasms by Site; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Study Officials

• Man Hu, Dr.

  Shandong Cancer Hospital and Institute Shandong First Medical University and Shandong Academy of Medical Sciences: Shandong Cancer Hospital and Institute

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Masking Details: This study is open-label, with no masking of any parties involved in the clinical trial. All participants, care providers, investigators, and outcomes assessors are aware of the interventions.
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief physician

Model Details: This is a Phase I/II, single-center, interventional clinical trial assessing the safety, efficacy, and prognostic value of \[18F\]AlF-NOTA-PCP2 PET/CT in evaluating PD-L1 expression in patients with malignant tumors. The study involves pre-treatment imaging with \[18F\]AlF-NOTA-PCP2 PET/CT, followed by correlation with PD-L1 expression in tumor samples and clinical outcomes.

Study Record Dates

• First Submitted: November 13, 2024
• First Posted: November 15, 2024
• Study Start: March 30, 2024
• Primary Completion: October 31, 2025
• Study Completion (Estimated): October 31, 2026
• Last Updated: March 30, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Start Date: The IPD and supporting information will be available starting after the completion of the primary analysis and publication of study results, which is expected to be by October 2025. End Date: The IPD and supporting information will be available for a period of 5 years following study completion, until October 2030.
• Access Criteria: Who will have access: Access to the individual participant data (IPD) and supporting information will be available to qualified researchers, healthcare professionals, and institutions involved in academic research or related scientific studies. This may include those interested in replicating the study results, conducting further analyses, or exploring the data for new scientific questions. What will be accessible: Researchers will have access to: The full individual participant data (IPD), including anonymized data related to clinical outcomes, imaging results (e.g., PET/CT scans), and laboratory tests. Supporting documents, such as the study protocol, statistical analysis plan (SAP), informed consent form (ICF), and the clinical study report (CSR), which provide details on the methodology, analysis approach, and results. How to access: Researchers can request access to the IPD and supporting information through the official study contact, Dr. Man Hu (contact: mhu@sdfmu.edu.cn). Upo

Locations

CN (1)