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

NCT ID: NCT04588064

Last Updated: 2025-01-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 63 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-01
• Study Completion Date: 2022-07-01

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

18F-FDG PET/CT scan

Each subject receives a single intravenous injection of 18F-FDG, and undergo PET/CT imaging within the specified time.

Group Type: EXPERIMENTAL

68Ga-FAPI PET/CT scan

Intervention Type: DIAGNOSTIC_TEST

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

Interventions

68Ga-FAPI PET/CT scan

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

Intervention Type: DIAGNOSTIC_TEST

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The First Affiliated Hospital of Xiamen University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Long Sun, PhD

Role: STUDY_DIRECTOR

The First Affiliated Hospital of Xiamen University, Fujian, China

Locations

The First Affiliated Hospital of Xiamen University

Xiamen, Fujian, China

Countries

China

References

Ruan 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 May 24. doi: 10.1007/s00259-025-07361-5. Online ahead of print.

Reference Type: DERIVED

PMID: 40411546 (View on PubMed)

Other Identifiers

KYZ2017-001

Identifier Type: -

Identifier Source: org_study_id