18F-FDG, 68Ga-FAPI, Lung Adenocarcinoma, PET/CT
Conditions
Keywords
Lung Adenocarcinoma, FDG, FAPI, PET/CT
Brief summary
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.
Detailed description
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.
Interventions
DIAGNOSTIC_TEST68Ga-FAPI PET/CT scan
Each subject receives a single intravenous injection of 68Ga-FAPI, and undergo PET/CT imaging within the specified time.
Sponsors
The First Affiliated Hospital of Xiamen University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
Participants with lung adenocarcinoma undergo contemporaneous 68Ga-FAPI and 18F-FDG PET/CT for tumor staging before treatment.
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* (i) aged ≥ 18 years, with newly detected GGNs ≤ 3 cm on LDCT and suspected to be lung cancer, and with no prior treatment; * (ii) who accepted undergoing paired 18F-FDG and 68Ga-FAPI-46 PET/CT, with completion within one week of each other; * (iii) with planned surgical resection within one month after PET/CT examinations; * (iv) with an ability to provide informed consent according to the guidelines of the Clinical Research Ethics Committee.
Exclusion criteria
* (i) without surgical treatment; * (ii) receiving antitumor treatment prior to surgery; * (iii) whose postoperative pathology revealed adenocarcinoma beyond stage IA or benign pulmonary lesions; * (iv) with concurrent diagnosis of other malignant tumors; * (v) with poor image quality or lesions difficult to measure.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cut-off value of SUVmax | 30 days | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 30 days | 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. |
Countries
China
Outcome results
None listed