Clinical Trial: 18F-FDS PET/CT in Healthy Volunteers and Patients With Suspected Infection

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Radiation Dosimetry, Plasma Pharmacokinetics, Biodistribution, Safety and Diagnostic Performance of 18F-FDS PET/CT in Healthy Volunteers and Patients With Suspected Infection

Brief 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.

Detailed Summary:

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.


Sponsor: Peking Union Medical College Hospital

Current Primary Outcome: Visual and semiquantitative assessment of lesions and biodistribution [ Time Frame: One year ]

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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Blood pressure [ Time Frame: 24 hours ]
    Blood pressure of healthy volunteers will be measured at three time points: right before injection, after scanning, and 24 hours after treatment.
  • Pulse [ Time Frame: 24 hours ]
    Pulse will be measured at three time points for each healthy volunteer: right before injection, after scanning, and 24 hours after treatment.
  • Respiration frequency [ Time Frame: 24 hours ]
    Respiration frequency will be measured at three time points for each healthy volunteer: right before injection, after scanning, and 24 hours after treatment.
  • Temperature [ Time Frame: 24 hours ]
    Temperature will be measured at three time points for each healthy volunteer: right before injection, after scanning, and 24 hours after treatment.
  • Routine blood test [ Time Frame: 24 hours ]
    Routine blood test of healthy volunteers will be measured at two time points: right before injection and 24 hours after treatment.
  • Routine urine test [ Time Frame: 24 hours ]
    Routine urine test of healthy volunteers will be measured at two time points: right before injection and 24 hours after treatment.
  • Serum alanine aminotransferase [ Time Frame: 24 hours ]
    Serum alanine aminotransferase of healthy volunteers will be measured at two time points: right before injection and 24 hours after treatment.
  • Serum albumin [ Time Frame: 24 hours ]
    Serum albumin of healthy volunteers will be measured at two time points: right before injection and 24 hours after treatment.
  • Serum creatinine [ Time Frame: 24 hours ]
    Serum creatinine of healthy volunteers will be measured at two time points: right before injection and 24 hours after treatment.
  • Adverse events collection [ Time Frame: 5 days ]
    Adverse events within 5 days after the injection and scanning of healthy volunteers and patients will be followed and assessed.


Original Secondary Outcome: Same as current

Information By: Peking Union Medical College Hospital

Dates:
Date Received: May 13, 2015
Date Started: January 2015
Date Completion: March 2018
Last Updated: April 5, 2017
Last Verified: May 2015