Clinical trial NCT02450942: 18F-FDS PET/CT in Healthy Volunteers and Patients With Suspected Infection
Official title: Radiation Dosimetry, Plasma Pharmacokinetics, Biodistribution, Safety and Diagnostic Performance of 18F-FDS PET/CT in Healthy Volunteers and Patients With Suspected Infection
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Enterobacteriaceae Infections
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2015-05-21
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Visual and semiquantitative assessment of lesions and biodistribution
timeFrame: One year
Secondary outcomes:
measure: Blood pressure
timeFrame: 24 hours
measure: Pulse
timeFrame: 24 hours
measure: Respiration frequency
timeFrame: 24 hours
measure: Temperature
timeFrame: 24 hours
measure: Routine blood test
timeFrame: 24 hours
measure: Routine urine test
timeFrame: 24 hours
measure: Serum alanine aminotransferase
timeFrame: 24 hours
measure: Serum albumin
timeFrame: 24 hours
measure: Serum creatinine
timeFrame: 24 hours
measure: Adverse events collection
timeFrame: 5 days
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
Study officials:
affiliation: Peking Union Medical College Hospital
name: Zhaohui Zhu
role: STUDY_CHAIR
References:
citation: Kong Z, Wang Y, Ma W, Cheng X. Role of 18F-fluorodeoxyglucose (FDG) and 18F-2-fluorodeoxy sorbitol (FDS) in autoimmune hypophysitis: a case report. BMC Endocr Disord. 2020 Jun 9;20(1):84. doi: 10.1186/s12902-020-00567-8.
citation: Yao S, Xing H, Zhu W, Wu Z, Zhang Y, Ma Y, Liu Y, Huo L, Zhu Z, Li Z, Li F. Infection Imaging With (18)F-FDS and First-in-Human Evaluation. Nucl Med Biol. 2016 Mar;43(3):206-14. doi: 10.1016/j.nucmedbio.2015.11.008. Epub 2015 Dec 4.