Skip to main content
OpenTrials
Completed

NCT Number: NCT04588064

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The First Affiliated Hospital of Xiamen University

Xiamen, Fujian, 0086-361000, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

68Ga-FAPI PET/CT scan

Diagnostic Test

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

Primary outcomes

  1. 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

  1. 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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital of Xiamen University

Other

Registry information

Official study title

Comparison of 18F-FDG and 68Ga-FAPI PET/CT in Patients with Lung Adenocarcinoma

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Oct 19, 2020
Registry last updated
Jan 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.