Clinical trial · Interventional
Clinical Application of Al18F-NOTA-FAPI-04 PET/CT or PET/MRI Imaging in Malignant Tumor,Cardiovascular or Immune Disease
NCT07400224CI-TRIAL-00102893recruitingPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This prospective, single-center study investigates the biodistribution, dosimetry, safety, diagnostic performance of Al18F-NOTA-FAPI PET imaging in patients with malignant tumor,cardiovascular or immune disease. And evaluates the potential of Al18F-NOTA-FAPI PET imaging in Clinical treatment strategy guidance.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cardiovascular Abnormalities | — | UNRESOLVED | — |
| Hyperthyroidism, Autoimmune | — | UNRESOLVED | — |
| Malignant Tumor | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Al18F-NOTA-FAPI PET/CT(or PET/MRI) | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Al18F-NOTA-FAPI PET/CT(PET/MRI)
- description
- Evaluation of dosimetry, safety, diagnostic accuracy, and clinical treatment strategy guidance ability of Al18F-NOTA-FAPI PET/CT(or PET/MRI) in patients with malignant tumor,cardiovascular or immune disease.
- interventionNames
- Other: Al18F-NOTA-FAPI PET/CT(or PET/MRI)
Primary outcomes (2)
- measure
- Safety of Al18F-NOTA-FAPI
- timeFrame
- From radiotracer injection to 24 hours post-injection.
- description
- Adverse effects were recorded according to CTCAE (version 5.0) after radiotracer injection and PET scan.
- measure
- Diagnostic accuracy of Al18F-NOTA-FAPI PET/CT(PET/MRI) for cardiovascular or immune disease.
- timeFrame
- Through study completion, 1-1.5 years .
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 88 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDYang X, Gan L, Shi X, Wu M, Li E, Zhang Y, Hao Z, Huang Z, Xing H, Liu X, Huo L. Integrated 18F-NOTA-FAPI-04 PET/MRI for quantitative assessment of disease activity in thyroid-associated ophthalmopathy. Eur J Nucl Med Mol Imaging. 2026 Aug 28. doi: 10.1007/s00259-026-08157-x. Online ahead of print. PMID 42660999