68Ga-NI-FAPI-04 PET/CT imaging to detect fibroblast activation in cancer, fibrotic, and heart diseases
Official title: Application of [68Ga]Ga-NI-FAPI-04 PET/CT Imaging in Fibroblast Activation Protein Related Diseases
Run by Peking Union Medical College Hospital · NCT07464132 · Data updated 2026-11-12
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 |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Enrollment | 30 (estimated) |
| Sponsor | Peking Union Medical College Hospital Academic / other |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Status | Recruiting |
| Started | December 17, 2025 |
| Main results expected | February 17, 2027 |
| Study ends | June 17, 2027 |
| Registry record updated | March 11, 2026 |
| Trial ID | NCT07464132 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
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
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.