68Ga-NK224 PET Imaging of PD-L1 Expression in Cancers

May 13, 2026 updated by: The First Affiliated Hospital of Xiamen University
To evaluate the potential usefulness of 68Ga-NK224 positron emission tomography/computed tomography (PET/CT) for the evaluation of PD-L1 expression in primary and/or metastatic tumors, compared with histopathological results.

Study Overview

Status

Recruiting

Conditions

Detailed Description

Participants with cancer underwent 68Ga-NK224 PET/CT for an initial assessment. Tumor uptake was quantified by the maximum standard uptake value (SUVmax) and mean SUV (SUVmean). In addition, the PD-L1 expression of lesions was confirmed by histopathological analyzing. The quantitative parameters of 68Ga-NK224 PET/CT were compared with histopathological result to evaluate the diagnostic efficacy.

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Fujian
      • Xiamen, Fujian, China, 361000
        • Recruiting
        • The first affiliated hospital of xiamen university
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

(i) adult patients (aged 18 years or order); (ii) patients with newly diagnosed or previously treated malignant tumors (supporting evidence may include magnetic resonance imaging (MRI), CT, tumor markers and pathology report); (iii) patients who had scheduled 68Ga-NK224 PET/CT scans; (iv) patients who were able to provide informed consent (signed by participant, parent or legal representative) and assent according to the guidelines of the Clinical Research Ethics Committee.

Description

Inclusion Criteria:

  • (i) adult patients (aged 18 years or order);
  • (ii) patients with newly diagnosed or previously treated malignant tumors (supporting evidence may include magnetic resonance imaging (MRI), CT, tumor markers and pathology report);
  • (iii) patients who had scheduled 68Ga-NK224 PET/CT scans;
  • (iv) patients who were able to provide informed consent (signed by participant, parent or legal representative) and assent according to the guidelines of the Clinical Research Ethics Committee.

Exclusion Criteria:

  • (i) patients with non-malignant lesions;
  • (ii) patients with pregnancy;
  • (iii) the inability or unwillingness of the research participant, parent or legal representative to provide written informed consent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Experimental: 68Ga-NK224 PET/CT
Each participant receives a single intravenous injection of 68Ga-NK224, and undergo PET/CT imaging within the specified time.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The concordance between 68Ga-NK224 PET/CT and histopathological result in PD-L1 expression
Time Frame: 30 Days
For 68Ga-NK224 PET/CT parameter, the maximum standard uptake value (SUVmax) is measured by defining a region of interest (ROI) around the primary tumor. For histopathological results, the level of PD-L1 expression is quantified as low (<1%), medium (1-49%), and high (>49%), respectively. Finally, Kruskal-Wallis test will be used to test the concordance between 68Ga-NK224 PET/CT and histopathological result in PD-L1 expression.
30 Days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate the intra- and inter- tumor heterogeneity
Time Frame: 30 Days
To assess inter-tumor heterogeneity, a quantitative measure of intratumoral heterogeneity, the heterogeneity index (HI), was calculated by dividing SUVmax by SUVmean for each lesion. Differences in 68Ga-NK224 uptake related to inter-tumor heterogeneity (between primary tumors and metastatic lesions) were analyzed using the Mann-Whitney U test.
30 Days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The First Affiliated Hospital of Xiamen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 30, 2023

Primary Completion (Estimated)

November 30, 2026

Study Completion (Estimated)

November 30, 2026

Study Registration Dates

First Submitted

December 24, 2024

First Submitted That Met QC Criteria

December 24, 2024

First Posted (Actual)

December 31, 2024

Study Record Updates

Last Update Posted (Actual)

May 15, 2026

Last Update Submitted That Met QC Criteria

May 13, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XMYY-2023KY146

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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