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NCT Number: NCT06754345

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

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.

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Key information

Conditions

Tumor Disease Neoplasms PD-L1 Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The First Affiliated Hospital of Xiamen University

Xiamen, Fujian, 361000, China

Location status: Recruiting

Location contact

Liang Zhao

CONTACT

[email protected]

86 0592-213-7366

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Liang Zhao

CONTACT

[email protected]

86 0592-213-7366

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital of Xiamen University

Other

Registry information

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Dec 31, 2024
Registry last updated
May 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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