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

The First Affiliated Hospital of Xiamen University63 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

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

Interventions

68Ga-FAPI PET/CT scanDIAGNOSTIC_TEST

Each subject receives a single intravenous injection of 68Ga-FAPI, and undergo PET/CT imaging within the specified time.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

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.

Locations (1)

The First Affiliated Hospital of Xiamen University

Xiamen, Fujian, China

Outcomes

Primary Outcomes

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

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

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

Data from ClinicalTrials.gov

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