18F-FDS PET/CT in Healthy Volunteers and Patients With Suspected Infection
Status:
Unknown status
Trial end date:
2018-03-01
Target enrollment:
Participant gender:
Summary
This is an open-label dynamic whole-body PET/CT (positron emission tomography/computed
tomography) study for investigation of radiation dosimetry, plasma pharmacokinetics,
biodistribution, safety and diagnostic performance of 18F-FDS in healthy volunteers and
patients with suspected infection. A single dose of nearly 370 MBq 18F-FDS will be
intravenously injected into healthy volunteers and patients with suspected infection. Visual
and semiquantitative method will be used to assess the PET/CT images. Changes of blood
pressure, pulse, respiration, temperature, routine blood and urine tests, serum alanine
aminotransferase, albumin, and creatinine, and any adverse events will be collected from the
volunteers. Adverse events will also be observed in the patients.