Clinical trial · Observational
68Ga-NK224 PET Imaging of PD-L1 Expression in Cancers
NCT06754345CI-TRIAL-00111764recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| PD-L1 | — | UNRESOLVED | — |
| Tumor | Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (1)
- label
- Experimental: 68Ga-NK224 PET/CT
- description
- Each participant receives a single intravenous injection of 68Ga-NK224, and undergo PET/CT imaging within the specified time.
Primary outcomes (1)
- measure
- The concordance between 68Ga-NK224 PET/CT and histopathological result in PD-L1 expression
- timeFrame
- 30 Days
- description
- 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)
- measure
- Evaluate the intra- and inter- tumor heterogeneity
- timeFrame
- 30 Days
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.