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Glioblastoma (GBM)Phase 1/2PD-L1-PETNCT06690216

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

A Phase 1/2 study testing PET/CT （[18F]AlF-NOTA-PCP2） and [18F]AlF-NOTA-PCP2 PET/CT Imaging for PD-L1 Expression in Malignant Tumors in people with Glioblastoma (GBM) and Head and Neck Squamous Cell Carcinoma, run by Man Hu at 1 site in China.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
PET/CT （[18F]AlF-NOTA-PCP2） and [18F]AlF-NOTA-PCP2 PET/CT Imaging for PD-L1 Expression in Malignant Tumors
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteChina
Study dates
30 Mar 2024to 31 Oct 2026
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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.

Who cannot join

  • 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).
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  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

China1 site

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

    Jinan, Shandong, 250117

Other trials in China

About this study

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

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.

Read the detailed description

This phase I/II clinical trial is designed to explore the utility of [18F]AlF-NOTA-PCP2 PET/CT in evaluating PD-L1 expression and its prognostic implications in patients with malignant tumors (glioblastoma, head and neck squamous cell carcinoma, non-small cell lung cancer, and esophageal cancer). The study involves at least 20 patients (5 per tumor type) who will undergo a pre-treatment PET/CT scan following an intravenous injection of [18F]AlF-NOTA-PCP2. The primary endpoints include the safety of the imaging protocol and the correlation between [18F]AlF-NOTA-PCP2 uptake (SUV values) and PD-L1 expression determined through immunohistochemistry (IHC). Secondary endpoints explore the dynamic changes in SUV values in patients undergoing multiple scans and their relationship with clinical outcomes.

Scientific and Technical Rationale:

[18F]AlF-NOTA-PCP2 is a novel radiotracer with high specificity for PD-L1, enabling non-invasive imaging of its expression in vivo. This imaging approach complements traditional immunohistochemical methods by offering whole-body assessment, eliminating the need for repeated biopsies, and providing insights into the tumor microenvironment. This study seeks to validate its application in clinical oncology, bridging molecular imaging with biomarker-guided therapeutic strategies.

Study Methods:

Patients will receive a single intravenous dose of [18F]AlF-NOTA-PCP2 (adjusted for body weight), followed by a whole-body PET/CT scan after one hour. Images will be analyzed independently by two experienced nuclear medicine specialists. Tumor biopsies will be collected to measure PD-L1 expression via IHC, and blood samples will be assessed for circulating and exosomal PD-L1 biomarkers. For patients undergoing multiple scans, changes in radiotracer uptake will be tracked to monitor treatment response.

Data Analysis:

SUV values will be correlated with PD-L1 expression levels, clinical factors (e.g., tumor stage, histology), and patient outcomes (PFS, OS). Statistical analyses, performed using SPSS 29.0, will include primary correlations and secondary evaluations of imaging-based dynamic changes and their relationship with therapeutic efficacy.

Significance:

This trial will provide critical data on the feasibility of [18F]AlF-NOTA-PCP2 PET/CT imaging in clinical oncology. Its potential to stratify patients based on PD-L1 expression and predict therapy response could transform personalized cancer care, optimizing immunotherapy outcomes and minimizing unnecessary treatments.

Timeline:

Patient enrollment is expected to last 12 months, with an additional 3 months of follow-up for data collection and analysis.

Being tested
PET/CT （[18F]AlF-NOTA-PCP2）, [18F]AlF-NOTA-PCP2 PET/CT Imaging for PD-L1 Expression in Malignant Tumors
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
Medical subject headings
Glioblastoma, Squamous Cell Carcinoma of Head and Neck, Carcinoma, Non-Small-Cell Lung, Esophageal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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 TumorsDiagnostic 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.

Study groups in NCT06690216
Study groupRoleWhat they receive
[18F]AlF-NOTA-PCP2 PET/CT Imaging for PD-L1 Expression in Malignant TumorsExperimentalThis 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.
Receives: Diagnostic Test: PET/CT （[18F]AlF-NOTA-PCP2）; Diagnostic Test: [18F]AlF-NOTA-PCP2 PET/CT Imaging for PD-L1 Expression in Malignant Tumors

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

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

Secondary outcomes (1)

  1. [18F]AlF-NOTA-PCP2 PET/CT imaging as a prognostic biomarker in malignant tumors

    This outcome will evaluate the prognostic value of [18F]AlF-NOTA-PCP2 PET/CT imaging in predicting clinical outcomes, including progression-free survival (PFS) and overall survival (OS), based on tumor PD-L1 expression.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Nov 2024
  2. Study start30 Mar 2024
  3. Primary completion31 Oct 2025 (estimated)
  4. Study completion31 Oct 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Model description
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.
Masking
None (open label)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06690216
Sponsor's protocol ID
ShandongCHI202410074
Other IDs
KY-2024-136
Acronym
PD-L1-PET
Status last verified
Nov 2024
First submitted
13 Nov 2024
Last updated
30 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: We plan to share individual participant data (IPD) from this clinical trial, including the following types of data: Data to be Shared: Demographic Data: Age, sex, and other basic demographic information. Clinical Data: Diagnosis, treatment regimens, disease stage, and clinical outcomes. Imaging Data: PET/CT scan images and associated quantitative data (e.g., SUV values) related to \[18F\]AlF-NOTA-PCP2 uptake. Biomarker Data: Results from PD-L1 expression assays, including tissue sample data and blood biomarkers. Adverse Event Data: Adverse event reports, including the type, severity, and outcome as graded by the NCI CTCAE. How the Data Will Be Shared: The IPD will be shared via a secure, password-protected database or a data-sharing platform. Access will be granted to qualified researchers upon submission of a data request proposal. The sharing process will include a data use agreement (DUA) that outlines the terms of use, data protection protocols, and the research purposes for which

Publications

  • 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.

    PubMed 38713298

  • 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.

    PubMed 38291578

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing PET/CT （[18F]AlF-NOTA-PCP2） and [18F]AlF-NOTA-PCP2 PET/CT Imaging for PD-L1 Expression in Malignant Tumors in people with Glioblastoma (GBM) and Head and Neck Squamous Cell Carcinoma, run by Man Hu at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 30 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Assessment of [18F]AlF-NOTA-PCP2 PET/CT imaging for PD-L1 expression in malignant tumors (time frame: Pre-treatment imaging, within 1-7 days before treatment initiation.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06690216, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2025.

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