An interventional study of 68Ga-FAPI PET/CT scan in Lung Adenocarcinoma, 18F-FDG and 68Ga-FAPI, sponsored by The First Affiliated Hospital of Xiamen University. Completed at 1 site in China. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2025-01-29.
Sponsored by The First Affiliated Hospital of Xiamen University · Not applicable, Interventional, and Diagnostic
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.
2,004 studies on the registry are indexed under Adenocarcinoma; 375 are open to participants now.
This study's enrollment of 63 is above the median of 45 across 1,553 interventional studies indexed under Adenocarcinoma.
Browse Adenocarcinoma studies →The First Affiliated Hospital of Xiamen University is the lead sponsor of 115 studies on the registry; 76 are open to participants now.
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Exclusion Criteria:
Each subject receives a single intravenous injection of 18F-FDG, and undergo PET/CT imaging within the specified time.
Diagnostic Test: 68Ga-FAPI PET/CT scan
Each subject receives a single intravenous injection of 68Ga-FAPI, and undergo PET/CT imaging within the specified time.
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.
Time frame: 30 days
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.
Time frame: 30 days
Plan to share: No
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This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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The First Affiliated Hospital of Xiamen University