Comparison of 18F-FDG and 68Ga-FAPI PET/CT in Patients with Lung Adenocarcinoma
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Lung Adenocarcinoma
- Sponsor
- The First Affiliated Hospital of Xiamen University
- Enrollment
- 63
- Locations
- 1
- Primary Endpoint
- Cut-off value of SUVmax
- Status
- Completed
- Last Updated
- last year
Overview
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.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Cut-off value of SUVmax
Time Frame: 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 Outcomes
- 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)