18F-FDS PET/CT in Healthy Volunteers and Patients With Suspected Infection
- Conditions
- Enterobacteriaceae Infections
- Interventions
- Drug: 18F-FDS
- Registration Number
- NCT02450942
- Lead Sponsor
- Peking Union Medical College Hospital
- 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 Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 30
-
Healthy volunteers:
o Males and females, ≥18 years old
-
Infectious patients:
- Males and females, ≥18 years old
- Characteristic clinical signs, symptoms and laboratory tests suggesting the diagnosis of infectious disease.
- The diagnosis of infection is based on The Centres for Disease Control and Prevention (CDC) criteria for diagnosing infection. They rely on a combination of clinical, radiological, operative, microbiological, and histological findings, in addition to results of other laboratory tests, such as the white blood cell count, erythrocyte sedimentation rate, and C reactive protein value.
- Females planning to bear a child recently or with childbearing potential
- Renal function: serum creatinine >3.0 mg/dL (270 μM/L)
- Liver function: any hepatic enzyme level more than 5 times upper limit of normal.
- Known severe allergy or hypersensitivity to IV radiographic contrast.
- Patients not able to enter the bore of the PET/CT scanner.
- Inability to lie still for the entire imaging time because of cough, pain, etc.
- Inability to complete the needed examinations due to severe claustrophobia, radiation phobia, etc.
- Concurrent severe and/or uncontrolled and/or unstable other medical disease that, in the opinion of the Investigator, may significantly interfere with study compliance.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 18F-FDS injection and PET/CT scan 18F-FDS The patients were intravenously injected with 18F-FDS and underwent PET/CT scan 1 h after the injection.
- Primary Outcome Measures
Name Time Method Visual and semiquantitative assessment of lesions and biodistribution 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.
- Secondary Outcome Measures
Name Time Method Blood pressure 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 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 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 24 hours Temperature will be measured at three time points for each healthy volunteer: right before injection, after scanning, and 24 hours after treatment.
Adverse events collection 5 days Adverse events within 5 days after the injection and scanning of healthy volunteers and patients will be followed and assessed.
Routine blood test 24 hours Routine blood test of healthy volunteers will be measured at two time points: right before injection and 24 hours after treatment.
Serum albumin 24 hours Serum albumin of healthy volunteers will be measured at two time points: right before injection and 24 hours after treatment.
Routine urine test 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 24 hours Serum alanine aminotransferase of healthy volunteers will be measured at two time points: right before injection and 24 hours after treatment.
Serum creatinine 24 hours Serum creatinine of healthy volunteers will be measured at two time points: right before injection and 24 hours after treatment.
Trial Locations
- Locations (1)
Peking Union Medical College Hospital
🇨🇳Beijing, Beijing, China