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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 68Ga-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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 68Ga-DOTA-hLAG-3 PET/CT | Diagnostic Test | Each participant receives a single intravenous injection of 68Ga-DOTA-hLAG-3, and undergo PET/CT imaging within the specified time. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The concordance between 68Ga-DOTA-hLAG-3 PET/CT and histopathological result in LAG-3 expression | 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. | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the inter-tumor heterogeneity | 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. | 30 days |
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Inclusion Criteria:
Exclusion Criteria:
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patients with newly diagnosed or previously treated malignant tumors(supporting evidence may include magnetic resonance imaging (MRI), CT, tumor markers and pathology report)
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| Name | Affiliation | Role |
|---|---|---|
| Long Sun, PhD | The First Affiliated Hospital of Xiamen University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First affiliated hospital of xiamen university | Xiamen | Fujian | 361000 | China |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D004194 | Disease |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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