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

Sponsor
Chang Gung Memorial Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05617742
Collaborator
(none)
103
1
1
37
2.8

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: 68Ga-FAPI-46
Phase 2

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 Design

Study Type:
Interventional
Anticipated Enrollment :
103 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
68Ga-FAPI PET in Evaluation of the Patient With Known or Suspected Lung Cancer: Comparison With Standard 18F-FDG PET
Anticipated Study Start Date :
Dec 1, 2022
Anticipated Primary Completion Date :
Dec 31, 2024
Anticipated Study Completion Date :
Dec 31, 2025

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. To define the diagnostic performance 68Ga-FAPI PET [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.

Secondary Outcome Measures

  1. To determine the safety profile of 68Ga-FAPI PET [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Department of Nuclear Medicine, Chang Gung Memorial Hospital Taoyuan Taiwan

Sponsors and Collaborators

  • Chang Gung Memorial Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
HO, KUNG-CHU, Principal Investigator, Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier:
NCT05617742
Other Study ID Numbers:
  • 202101258A0
First Posted:
Nov 15, 2022
Last Update Posted:
Nov 18, 2022
Last Verified:
Nov 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by HO, KUNG-CHU, Principal Investigator, Chang Gung Memorial Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 18, 2022