Comparing two imaging techniques for lung cancer diagnosis
68Ga-FAPI PET in Evaluation of the Patient With Known or Suspected Lung Cancer: Comparison With Standard 18F-FDG PET
This study is testing a new imaging technique called 68Ga-FAPI-46 PET to see if it can diagnose lung cancer better than the standard 18F-FDG PET method.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 103 (estimated) |
| Ages | 20 Years and up |
| Sex | All |
| Sponsor | Chang Gung Memorial Hospital Academic / other |
| Locations | 1 site (Taoyuan) |
| Trial ID | NCT05617742 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of 68Ga-FAPI-46 PET imaging compared to the standard 18F-FDG PET for diagnosing primary and metastatic lung cancer lesions. It is a prospective, single-center, open-label study that aims to address the limitations of FDG-PET, which can produce false-positive and false-negative results. By using 68Ga-FAPI-46, the study seeks to determine if it provides a higher diagnostic performance with better tumor-to-background ratios. Patients with confirmed lung cancer or those with ground-glass opacities on chest CT who are scheduled for FDG-PET will be included.
Who should consider this trial
Good fit: Ideal candidates are adults over 20 years old with histologically confirmed lung cancer or those with suspicious lesions on chest CT.
Not a fit: Patients who are pregnant, lactating, or have contraindications to PET imaging will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more accurate diagnosis and staging of lung cancer, improving treatment outcomes.
How similar studies have performed: While FDG-PET is widely used, the novel use of 68Ga-FAPI-46 PET has shown promising results in other cancers, suggesting potential success in this application.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Taoyuan
- Department of Nuclear Medicine, Chang Gung Memorial Hospital — Taoyuan, Taiwan (Recruiting)
Study contacts
- Principal investigator: Kung-Chu Ho, MD — Chang Gung Memorial Hospital
- Study coordinator: Kung-Chu Ho, MD
- Email: b8301068@gmail.com
- Phone: +886975365783
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.