Using 68Ga-FAPI PET/CT to assess fibrotic diseases
68Ga-DOTA/NOTA-FAPI PET/CT in Patients With Various Fibrotic Disease
This study is testing if a new type of PET/CT scan can help doctors better diagnose and predict outcomes for people with different fibrotic diseases compared to standard tests like MRI and blood tests.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 500 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | First Affiliated Hospital of Fujian Medical University Academic / other |
| Locations | 1 site (Fuzhou, Fujian) |
| Trial ID | NCT04831034 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of 68Ga-FAPI-04 positron emission tomography/computed tomography (PET/CT) in diagnosing and predicting outcomes in patients with various fibrotic diseases. Participants will undergo PET/CT scanning to measure the uptake of fibrosis lesions, which will be compared against conventional assessments like MRI, biopsy, and blood tests. The study aims to determine the diagnostic accuracy of PET/CT in relation to these traditional methods.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with suspected or newly diagnosed fibrotic disease.
Not a fit: Patients who are pregnant or unable to provide informed consent will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more accurate diagnosis and better management of fibrotic diseases.
How similar studies have performed: While the use of PET/CT in fibrotic diseases is emerging, this specific application of 68Ga-FAPI is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * adult patients (aged 18 years or order) * patients with suspected or new diagnosed fibrotic disease (supporting evidence may include , BBI, MRI, CT and pathology report) * patients who had scheduled 68Ga-FAPI-04 PET/CT scan * 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: * patients with pregnancy * the inability or unwillingness of the research participant, parent or legal representative to provide written informed consent
Where this trial is running
Fuzhou, Fujian
- Department of Nuclear Medicine, First Affiliated Hospital of Fujian Medical University — Fuzhou, Fujian, China (Recruiting)
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.