18F-FDG and 68Ga-FAPI PET/CT in Lung Adenocarcinoma

Not Applicable

Completed

• Conditions: Lung Adenocarcinoma; PET/CT; 68Ga-FAPI; 18F-FDG
• Interventions: Diagnostic Test: 68Ga-FAPI PET/CT scan

• Registration Number: NCT04588064
• Lead Sponsor: The First Affiliated Hospital of Xiamen University

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.

Study Timeline

• Study Start: 2020-07-01
• Study First Submitted: 2020-09-13
• Study First Submitted QC: 2020-10-09
• Study First Posted: 2020-10-19
• Primary Completion: 2022-07-01
• Study Completion: 2022-07-01
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-26
• Last Update Posted: 2025-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 63

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
18F-FDG PET/CT scan	68Ga-FAPI PET/CT scan	Each subject receives a single intravenous injection of 18F-FDG, and undergo PET/CT imaging within the specified time.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

The First Affiliated Hospital of Xiamen University; 🇨🇳 Xiamen, Fujian, China