An Early Phase 1 interventional study of 18F-FDS in Enterobacteriaceae Infections, sponsored by Peking Union Medical College Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-04-07.
Sponsored by Peking Union Medical College Hospital · Early Phase 1, Interventional, and Diagnostic
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.
In clinical microbiology, pathogenic enterobacteriaceae are differentiated from other organisms by selectively metabolizing sorbitol. They exclusively express the enzyme sorbitol-6-phosphate dehydrogenase, which is the enzyme responsible for initiating sorbitol metabolism. 2-[18F]-fluorodeoxysorbitol (18F-FDS) is a positron-emitting analog of sorbitol. The substitution of the hydroxyl group by fluorine at the C-2 position, however, completely abrogates the recognition by mammalian sorbitol dehydrogenase.18F-FDS could be a suitable probe to selectively label and tomographically image enterobacteriaceae in vivo.
For further interests in clinical translation of 18F-FDS, an open-label dynamic whole-body PET/CT study was designed to investigate 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.
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's planned enrollment of 30 is below the median of 120 across 4,200 interventional studies indexed under Infections.
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Healthy volunteers:
o Males and females, ≥18 years old
Infectious patients:
Exclusion Criteria:
The patients were intravenously injected with 18F-FDS and underwent PET/CT scan 1 h after the injection.
Drug: 18F-FDS
18F-FDS were intravenously injected into the patients 1 h before the PET/CT scans
Also known as: 2-[18F]-fluorodeoxysorbitol
Visual and semiquantitative assessment of lesions and biodistribution
Visual analysis will be performed by consensus reading by at least 3 experienced nuclear medicine physician. The semiquantitative analysis will be performed by the same person for all the cases, and the standardized uptake values (SUVs) of tumor and organs will be measured.
Time frame: One year
Blood pressure
Blood pressure of healthy volunteers will be measured at three time points: right before injection, after scanning, and 24 hours after treatment.
Time frame: 24 hours
Pulse
Pulse will be measured at three time points for each healthy volunteer: right before injection, after scanning, and 24 hours after treatment.
Time frame: 24 hours
Respiration frequency
Respiration frequency will be measured at three time points for each healthy volunteer: right before injection, after scanning, and 24 hours after treatment.
Time frame: 24 hours
Temperature
Temperature will be measured at three time points for each healthy volunteer: right before injection, after scanning, and 24 hours after treatment.
Time frame: 24 hours
Routine blood test
Routine blood test of healthy volunteers will be measured at two time points: right before injection and 24 hours after treatment.
Time frame: 24 hours
Routine urine test
Routine urine test of healthy volunteers will be measured at two time points: right before injection and 24 hours after treatment.
Time frame: 24 hours
Serum alanine aminotransferase
Serum alanine aminotransferase of healthy volunteers will be measured at two time points: right before injection and 24 hours after treatment.
Time frame: 24 hours
Serum albumin
Serum albumin of healthy volunteers will be measured at two time points: right before injection and 24 hours after treatment.
Time frame: 24 hours
Serum creatinine
Serum creatinine of healthy volunteers will be measured at two time points: right before injection and 24 hours after treatment.
Time frame: 24 hours
Adverse events collection
Adverse events within 5 days after the injection and scanning of healthy volunteers and patients will be followed and assessed.
Time frame: 5 days
Plan to share: No
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Peking Union Medical College Hospital