NCT07400224

Clinical Application of Al18F-NOTA-FAPI-04 PET/CT or PET/MRI Imaging in Malignant Tumor,Cardiovascular or Immune Disease

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 600 (estimated)
• Sponsor: Peking Union Medical College Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 88 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

FAP is expected to become an important indicator for predicting tumor prognosis, and also a new target for individualized treatment of various diseases such as tumors, rheumatoid arthritis, myocardial infarction, and thyroid-associated ophthalmopathy. The biological distribution of FAP in healthy adults is not yet clear. It is planned to obtain the normal PET/CT (or PET/MRI) images of healthy subjects after they use this tracer, in order to establish a benchmark for future application in patients.

Conditions

• Hyperthyroidism, Autoimmune
• Cardiovascular Abnormalities
• Malignant Tumor

Interventions

Type	Name	Description
OTHER	Al18F-NOTA-FAPI PET/CT(or PET/MRI)	Participants will receive an intravenous injection of Al18F-NOTA-FAPI, prepared on-site and measured by qualified personnel using a dose calibrator, with readings and time recorded. The radiopharmaceutical will be slowly administered through a three-way stopcock, followed by a flush with 5 mL of normal saline. The recommended dose is approximately 4.81 MBq/kg (0.13 mCi/kg) body weight, with variations depending on drug yield and clinical scheduling. PET/CT(or PET/MRI) imaging are planned 45-90 minutes after administration, with adjustments based on drug yield and equipment availability.

Timeline

• Start date: 2022-05-10
• Primary completion: 2027-12-31
• Completion: 2028-12-31
• First posted: 2026-02-10
• Last updated: 2026-02-10

Locations

1 site across 1 country: China