68Ga-NK224 PET Imaging of PD-L1 Expression in Cancers
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Tumor, PD-L1. Basic parameters: 18 years — 90 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
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.
Primary outcome measures
- The concordance between 68Ga-NK224 PET/CT and histopathological result in PD-L1 expression [Time frame: 30 Days]
Secondary outcome measures (1)
- Evaluate the intra- and inter- tumor heterogeneity [Time frame: 30 Days]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Other
Study locations
China · 1 center
- The First Affiliated Hospital of Xiamen University — Xiamen
Identifiers
NCT: NCT06754345 · XMYY-2023KY146