Comparison of 68Ga-FAPI-46 PET and 18F-FDG PET in Lung Cancer

May 10, 2026 updated by: HO, KUNG-CHU, Chang Gung Memorial Hospital

68Ga-FAPI PET in Evaluation of the Patient With Known or Suspected Lung Cancer: Comparison With Standard 18F-FDG PET

This is a prospective, single-center, single arm, open label study to evaluate the performance of 68Ga-FAPI-46 for the diagnosis of primary and metastatic lesions of lung cancer with comparison to 18F-FDG PET.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

FDG-PET imaging is recommended by clinical guidelines for staging of lung cancer; however, there are still limitations of FDG-PET in lung cancer staging due to false-positive and false-negative findings. 68Ga-FAPI PET images have shown high diagnostic performance with high tumor-to-background ratio in various cancers. The purpose of this study is head-to-head comparison of 68Ga-FAPI-46 PET and 18F-FDG PET for the diagnosis and staging or re-staging of lung cancer.

Study Type

Interventional

Enrollment (Actual)

58

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taoyuan, Taiwan
        • Department of Nuclear Medicine, Chang Gung Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age > 20 years
  2. Informed consent obtained from patients and families
  3. Patients with histology confirmed lung cancer or patients with GGO on chest CT planned to have biopsy or surgery
  4. Patients scheduled to undergo FDG-PET examination
  5. Performance status: 0, 1, 2, 3

Exclusion Criteria:

  1. Contraindication to FAPI-PET and FDG-PET such as pregnant, or lactating patients
  2. Patients with mainly malignant pleural effusion without other measurable lesions
  3. Undergoing irradiation at accrual
  4. Active infection or other serious underlying medical conditions not compatible with study entry
  5. History of significant neurological or psychiatric disorders including dementia that would prohibit the understanding and giving of informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 68Ga-FAPI-46 PET Scan
A single-center prospective interventional single-arm clinical trial. All patients will undergo whole-body 68Ga-FAPI-46 PET scan within two weeks before or after 18F-FDG-PET. Injected activity of 68Ga-FAPI-46 is limited to 100-250 MBq per examination.
Diagnostic test: 68Ga-FAPI-46
68Ga-FAPI-46 is a radioactive diagnostic agent for PET imaging in the detection of Fibroblast Activation Protein (FAP) positive tumor cells in cancer patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To define the diagnostic performance 68Ga-FAPI PET
Time Frame: Through study completion, 2 years
To evaluate the diagnostic performance (sensitivity, specificity, accuracy) of the 68Ga-FAPI-46 PET scan for identification and staging of lung cancer with comparison to 18F-FDG PET. Histopathology and clinical follow-up will be used as truth standard.
Through study completion, 2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To determine the safety profile of 68Ga-FAPI PET
Time Frame: Up to 7 days post injection with 68Ga-FAPI-46
Number of participants with 68Ga-FAPI-46 PET scan related adverse events assessed by CTCAE v5.0
Up to 7 days post injection with 68Ga-FAPI-46

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chang Gung Memorial Hospital

Investigators

  • Principal Investigator: Kung-Chu Ho, MD, Chang Gung Memorial Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2022

Primary Completion (Actual)

January 31, 2026

Study Completion (Actual)

January 31, 2026

Study Registration Dates

First Submitted

November 8, 2022

First Submitted That Met QC Criteria

November 8, 2022

First Posted (Actual)

November 15, 2022

Study Record Updates

Last Update Posted (Actual)

May 13, 2026

Last Update Submitted That Met QC Criteria

May 10, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202101258A0

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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