Clinical trial · Interventional
18F-FDG and 68Ga-FAPI PET/CT in Lung Adenocarcinoma
Comparison of 18F-FDG and 68Ga-FAPI PET/CT in Patients with Lung Adenocarcinoma
NCT04588064CI-TRIAL-00085240completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| 18F-FDG | — | UNRESOLVED | — |
| 68Ga-FAPI | — | UNRESOLVED | — |
| Lung Adenocarcinoma | Lung Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
| PET/CT | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 68Ga-FAPI PET/CT scan | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 18F-FDG PET/CT scan
- description
- Each subject receives a single intravenous injection of 18F-FDG, and undergo PET/CT imaging within the specified time.
- interventionNames
- Diagnostic Test: 68Ga-FAPI PET/CT scan
Primary outcomes (1)
- measure
- Cut-off value of SUVmax
- timeFrame
- 30 days
- description
- 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 (1)
- measure
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDRuan 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. PMID 40411546