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

NCT04588064 | Completed DMC

• 1 other identifier: KYZ2017-001
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Lung Adenocarcinoma; FDG; FAPI; PET/CT

Outcome Measures

Primary Outcomes (1)

• 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.

  30 days

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

  30 days

Study Arms (1)

18F-FDG PET/CT scan

EXPERIMENTAL

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

Diagnostic Test: 68Ga-FAPI PET/CT scan

Interventions

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.

18F-FDG PET/CT scan

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (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.

You may not qualify if:

• (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.

Sponsors & Collaborators

• The First Affiliated Hospital of Xiamen University: lead

Study Sites (1)

The First Affiliated Hospital of Xiamen University

Xiamen, Fujian, 0086-361000, China

Location

Related Publications (1)

• 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 Nov;52(13):4788-4805. doi: 10.1007/s00259-025-07361-5. Epub 2025 May 24.

  PMID: 40411546 DERIVED

MeSH Terms

Conditions

Adenocarcinoma of Lung

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site

Study Officials

• Long Sun, PhD

  The First Affiliated Hospital of Xiamen University, Fujian, China

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants with lung adenocarcinoma undergo contemporaneous 68Ga-FAPI and 18F-FDG PET/CT for tumor staging before treatment.

Study Record Dates

• First Submitted: September 13, 2020
• First Posted: October 19, 2020
• Study Start: July 1, 2020
• Primary Completion: July 1, 2022
• Study Completion: July 1, 2022
• Last Updated: January 29, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)