Al18F‑NOTA‑FAPI PET imaging for cancer, cardiovascular, and autoimmune conditions
Official title: Clinical Application of Al18F-NOTA-FAPI-04 PET/CT or PET/MRI Imaging in Malignant Tumor,Cardiovascular or Immune Disease
Run by Peking Union Medical College Hospital · NCT07400224 · Data updated 2026-11-12
This trial will test a new PET tracer called Al18F‑NOTA‑FAPI to image fibroblast activity in adults with cancer, heart disease, or autoimmune conditions and in healthy volunteers to see how safe and useful it is for guiding care.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 88 Years |
| Sex | All |
| Enrollment | 600 (estimated) |
| Sponsor | Peking Union Medical College Hospital Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Beijing) |
| Status | Recruiting |
| Started | May 10, 2022 |
| Main results expected | December 31, 2027 |
| Study ends | December 31, 2028 |
| Registry record updated | February 10, 2026 |
| Trial ID | NCT07400224 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 or older who either have a known malignant tumor, cardiovascular abnormality, or autoimmune condition and need imaging, or healthy volunteers who had a recent normal health check and meet the study's radiation exposure criteria.
✕Probably not a fit
People who recently had CT or PET/CT scans within the study's exclusion windows, pregnant individuals, or those with unstable major illnesses are unlikely to be eligible or 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
This is a prospective, single‑center Phase 1/2 study of Al18F‑NOTA‑FAPI PET/CT or PET/MRI that will measure biodistribution, radiation dosimetry, safety, and diagnostic performance in patients with malignant tumors, cardiovascular abnormalities, or immune diseases and in healthy adults. Healthy volunteers will undergo PET/CT or PET/MRI to establish normal reference images for future comparisons. Patients will receive the tracer and undergo imaging with either PET/CT or PET/MRI, with follow‑up to monitor safety and imaging findings. The study will also explore whether tracer uptake patterns could help guide clinical treatment decisions.
Why it matters
Potential benefit: If successful, this imaging approach could help clinicians locate and quantify fibroblast activation to improve diagnosis and better tailor treatments for tumors, heart disease, and immune disorders.
How similar studies have gone: FAPI‑targeted PET imaging has shown promising diagnostic results in several early studies across oncology and fibrotic conditions, though Al18F‑NOTA‑FAPI is a newer tracer with limited published clinical data to date.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * a. Age 18 years old or above, gender not restricted. b. Have undergone a health check-up within the last 3 months (at least completed chest X-ray / chest CT and abdominal B-ultrasound and other examinations), and no major diseases were found. Exclusion Criteria: * As this study involves certain radiation exposure, patients who have had frequent radiation exposure due to clinical needs (those who have undergone a CT or PET/CT examination once within 3 months or 1 month respectively) are not included in the study.
Where it's running
-
Peking Union Medical College Hospital
Beijing, China Recruiting
Study contacts
- Study coordinator: Li Huo, MD
- Email: huoli@pumch.cn
- Phone: +86 18612672038
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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.