68Ga-NI-FAPI-04 PET/CT imaging to detect fibroblast activation in cancer, fibrotic, and heart diseases
Application of [68Ga]Ga-NI-FAPI-04 PET/CT Imaging in Fibroblast Activation Protein Related Diseases
This test will see if an injected PET tracer called 68Ga-NI-FAPI-04 can better show fibroblast activation in people with tumors, pulmonary fibrosis, certain autoimmune vascular diseases, hypertrophic cardiomyopathy, or other cardiovascular conditions.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Peking Union Medical College Hospital Academic / other |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT07464132 on ClinicalTrials.gov |
What this trial studies
Participants receive an injection of 68Ga-NI-FAPI-04 followed by PET/CT imaging to visualize fibroblast activation across different diseases. The trial enrolls adults 18–85 including patients with pathologically confirmed tumors, pulmonary fibrosis, large-vessel rheumatic immune disease, hypertrophic cardiomyopathy, other cardiovascular conditions, and healthy volunteers. Phase 1 will emphasize safety and dosimetry while phase 2 examines imaging characteristics and diagnostic performance. Key exclusions include pregnancy or lactation, allergy to the tracer, severe liver or kidney dysfunction, participation in conflicting trials, or inability to cooperate with imaging procedures, and all imaging is performed at Peking Union Medical College Hospital in Beijing.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18–85 who can consent and either have pathologically confirmed tumors or diagnosed fibroblast-related conditions (pulmonary fibrosis, specified autoimmune large-vessel disease, hypertrophic cardiomyopathy, or other cardiovascular diseases), or healthy volunteers meeting the study's health criteria, with expected survival over six months.
Not a fit: People who are pregnant or breastfeeding, allergic to the tracer, have severe liver or kidney dysfunction, are too ill to undergo imaging, or are enrolled in conflicting trials are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, this imaging approach could enable earlier or more accurate detection of fibroblast-driven disease activity and help guide treatment or monitoring without invasive biopsies.
How similar studies have performed: Other FAP-targeted PET tracers have shown promising imaging results in cancers and fibrotic diseases in prior research, though 68Ga-NI-FAPI-04 itself is being tested in early-phase trials.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 1: 18-85 years old 2: Tumor patients can undergo surgery or biopsy to obtain pathological diagnosis 3: Ability to understand and sign informed consent forms 4: Expected survival period exceeding 6 months and able to receive follow-up 5: Healthy volunteers without chronic medical history of hypertension, diabetes, coronary heart disease, kidney disease, tumor, etc Exclusion Criteria: * 1: Pregnant or lactating women 2: Patients allergic to research drug ingredients 3: Patients with severe liver and kidney dysfunction (blood creatinine levels exceeding 159 μ mol/L) 4: Patients who participate in other clinical trials and interfere with the results of this study 5: Patients with severe illness who cannot cooperate with the examination
Where this trial is running
Beijing, Beijing Municipality
- Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Study coordinator: Zhu
- Email: yfwyw1999@126.com
- Phone: +86-13021115973
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.