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To evaluate the potential usefulness of 68Ga-FAPI positron emission tomography/computed tomography (PET/CT) for the diagnosis of primary and metastatic lesions in lung adenocarcinoma, compared with 18F-FDG PET/CT.
Participants with lung adenocarcinoma underwent contemporaneous 18F-FDG and 68Ga-FAPI PET/CT for an initial assessment. Tumor uptake was quantified by the maximum standard uptake value (SUVmax). The sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and accuracy of 18F-FDG and 68Ga-FAPI PET/CT were calculated and compared to evaluate the diagnostic efficacy. In addition, the investigators further investigate the performance of 68Ga-FAPI PET/CT for differentiating invasive adenocarcinoma from adenocarcinoma in situ (pre-invasive lesion) or minimally invasive adenocarcinoma in participants with solitary ground-glass opacity nodules.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 18F-FDG PET/CT scan | Experimental | Each subject receives a single intravenous injection of 18F-FDG, and undergo PET/CT imaging within the specified time. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 68Ga-FAPI PET/CT scan | Diagnostic Test | Each subject receives a single intravenous injection of 68Ga-FAPI, and undergo PET/CT imaging within the specified time. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cut-off value of SUVmax | Using the cut-off value of SUVmax derived from 68Ga-FAPI-46 PET to distinguish IAC from pre-invasive lesions (including atypical adenomatous hyperplasia (AAH), adenocarcinoma in situ (AIS), and minimally invasive adenocarcinoma (MIA)) in GGNs. | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| The area under the receiver operating characteristic (ROC) curve (AUC), accuracy, sensitivity, specificity, p-value [indicating accuracy exceeding the No-Information Rate], and kappa value | Based on clinical features (age, sex, smoking history) and PET/CT parameters (including SUVmax, TBR, CT value), calculate the diagnostic performance. Based on 68Ga-FAPI-46 PET/CT radiomics features, calculate the diagnostic performance and explain the most significant predictors. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Long Sun, PhD | The First Affiliated Hospital of Xiamen University, Fujian, China | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Xiamen University | Xiamen | Fujian | 0086-361000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40411546 | Derived | Ruan D, Shi S, Guo W, Pang Y, Yu L, Cai J, Wu Z, Wu H, Sun L, Zhao L, Chen H. Evaluation of locoregional invasiveness of early lung adenocarcinoma manifesting as ground-glass nodules via [68Ga]Ga-FAPI-46 PET/CT imaging. Eur J Nucl Med Mol Imaging. 2025 Nov;52(13):4788-4805. doi: 10.1007/s00259-025-07361-5. Epub 2025 May 24. |
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| ID | Term |
|---|---|
| D000077192 | Adenocarcinoma of Lung |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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Participants with lung adenocarcinoma undergo contemporaneous 68Ga-FAPI and 18F-FDG PET/CT for tumor staging before treatment.
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| 30 days |
| D009369 | Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |