hLAG-3, PET/CT, TUMOR
Conditions
Keywords
Tumor, PET/CT, diagnosis, hLAG-3
Brief summary
To evaluate the potential usefulness of 68Ga-DOTA-hLAG-3 positron emission tomography/computed tomography (PET/CT) for the evaluation of LAG-3 expression in primary and/or metastatic tumors, compared with histopathological results.
Detailed description
Participants with cancer underwent 68Ga-DOTA-hLAG-3 PET/CT for an initial assessment. Tumor uptake was quantified by the maximum standard uptake value (SUVmax) and mean SUV (SUVmean). In addition, the LAG-3 expression of lesions was confirmed by histopathological analyzing. The quantitative parameters of 68Ga-DOTA-hLAG-3 PET/CT were compared with histopathological result to evaluate the diagnostic efficacy.
Interventions
DIAGNOSTIC_TEST68Ga-DOTA-hLAG-3 PET/CT
Each participant receives a single intravenous injection of 68Ga-DOTA-hLAG-3, and undergo PET/CT imaging within the specified time.
Sponsors
The First Affiliated Hospital of Xiamen University
Study design
Observational model
OTHER
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The concordance between 68Ga-DOTA-hLAG-3 PET/CT and histopathological result in LAG-3 expression | 30 days | For 68Ga-DOTA-hLAG-3 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 LAG-3 expression is quantified as low (\<1%), medium (1-49%), and high (\>49%), respectively. Finally, one-way ANOVA tast will be used to test the concordance between 68Ga-DOTA-hLAG-3 PET/CT and histopathological result in LAG-3 expression. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate the inter-tumor heterogeneity | 30 days | For the inter-tumor heterogeneity, the investigators will use the Wilcoxon test to compare the SUVmax values of primary tumor and metastases, which are measured by 68Ga-DOTA-hLAG-3 PET/CT, for indirectly evaluating the inter-tumor heterogeneity. |
Countries
China
Outcome results
None listed