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

Recruiting

• Conditions: Tumor; PD-L1

• Registration Number: NCT06754345
• Lead Sponsor: The First Affiliated Hospital of Xiamen University

Brief 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.

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.

Study Timeline

• Study Start: 2023-12-31
• Status Verified: 2024-12
• Study First Submitted: 2024-12-24
• Study First Submitted QC: 2024-12-24
• Last Update Submitted: 2024-12-24
• Study First Posted: 2024-12-31
• Last Update Posted: 2024-12-31
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
Evaluate the intra- and inter- tumor heterogeneity	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.

Trial Locations

Locations (1)

The First Affiliated Hospital of Xiamen University; 🇨🇳 Xiamen, Fujian, China