About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
(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.
Disqualifiers
(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.
Trial 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.
Trial design
Other
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
The concordance between 68Ga-NK224 PET/CT and histopathological result in PD-L1 expression
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
Evaluate the intra- and inter- tumor heterogeneity
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.
Sponsors and contacts
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