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RECRUITING
NCT07400224
PHASE1/PHASE2

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

Sponsor: Peking Union Medical College Hospital

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - 88 Years

Study Type

INTERVENTIONAL

Enrollment

600

Start Date

2022-05-10

Completion Date

2028-12-31

Last Updated

2026-02-10

Healthy Volunteers

Yes

Interventions

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.

Locations (1)

Peking Union Medical College Hospital

Beijing, China