Comparing two types of PET scans for cancer diagnosis
Comparison of FDG and FAPI in Patients With Various Types of Cancer
This study is testing whether a new type of PET scan can find cancer better than the standard scan in patients who have or might have tumors.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 3000 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | The First Affiliated Hospital of Xiamen University Academic / other |
| Locations | 1 site (Xiamen, Fujian) |
| Trial ID | NCT04416165 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of 68Ga-DOTA-FAPI-04 positron emission tomography/computed tomography (PET/CT) in diagnosing primary and metastatic lesions in various cancers, compared to the standard 18F-FDG PET/CT. Patients with suspected or diagnosed malignant tumors will undergo both types of scans, and the results will be analyzed for sensitivity, specificity, and overall diagnostic accuracy. The goal is to determine which imaging method provides better diagnostic information for cancer detection and monitoring.
Who should consider this trial
Good fit: Ideal candidates include adult patients aged 18 or older with suspected or diagnosed malignant tumors who can provide informed consent.
Not a fit: Patients with non-malignant lesions or those who are pregnant will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the accuracy of cancer diagnosis and monitoring, leading to better patient outcomes.
How similar studies have performed: Other studies have shown promising results with similar imaging techniques, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * (i) adult patients (aged 18 years or order); (ii) patients with suspected or newly diagnosed or previously treated malignant tumors (supporting evidence may include magnetic resonance imaging (MRI), CT, tumor markers and pathology report); (iii) patients who had scheduled both 18F-FDG and 68Ga-DOTA-FAPI-04 PET/CT scans; (iv) patients who were able to provide informed consent (signed by participant, parent or legal representative) and assent according to the guidelines of the Clinical Research Ethics Committee. Exclusion Criteria: * (i) patients with non-malignant lesions; (ii) patients with pregnancy; (iii) the inability or unwillingness of the research participant, parent or legal representative to provide written informed consent.
Where this trial is running
Xiamen, Fujian
- First affiliated hospital of xiamen university — Xiamen, Fujian, China (Recruiting)
Study contacts
- Study coordinator: Hua Wu, PhD
- Email: wuhua1025@163.com
- Phone: 86 0592-2137166
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.