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Clinical Trials in China / NCT06754345
Recruiting Observational

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

NCT06754345 · tracked via the Priya Life Science China tracker
Sponsor
The First Affiliated Hospital of Xiamen University
Phase
Observational
Started
2023-05-30
Last updated
2026-05-15

Condition(s) studied

TumorPD-L1

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
90 Years
Healthy volunteers
Accepted
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.

Primary outcome measure(s)

  • The concordance between 68Ga-NK224 PET/CT and histopathological result in PD-L1 expression — 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.

Trial sites (1)

FacilityCityRegionStatus
The First Affiliated Hospital of Xiamen University Xiamen Fujian Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06754345 on ClinicalTrials.gov ↗ ← All trials in China