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

Primary Purpose

Enterobacteriaceae Infections

Status
Unknown status
Phase
Early Phase 1
Locations
China
Study Type
Interventional
Intervention
18F-FDS
Sponsored by
Peking Union Medical College Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Enterobacteriaceae Infections

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Peking Union Medical College HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

18F-FDS injection and PET/CT scan

Arm Description

The patients were intravenously injected with 18F-FDS and underwent PET/CT scan 1 h after the injection.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
May 13, 2015
Last Updated
April 5, 2017
Sponsor
Peking Union Medical College Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02450942
Brief Title
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

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Unknown status
Study Start Date
January 2015 (undefined)
Primary Completion Date
January 2018 (Anticipated)
Study Completion Date
March 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Peking Union Medical College Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Enterobacteriaceae Infections

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
18F-FDS injection and PET/CT scan
Arm Type
Experimental
Arm Description
The patients were intravenously injected with 18F-FDS and underwent PET/CT scan 1 h after the injection.
Intervention Type
Drug
Intervention Name(s)
18F-FDS
Other Intervention Name(s)
2-[18F]-fluorodeoxysorbitol
Intervention Description
18F-FDS were intravenously injected into the patients 1 h before the PET/CT scans
Primary Outcome Measure Information:
Title
Visual and semiquantitative assessment of lesions and biodistribution
Description
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
Secondary Outcome Measure Information:
Title
Blood pressure
Description
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
Title
Pulse
Description
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
Title
Respiration frequency
Description
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
Title
Temperature
Description
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
Title
Routine blood test
Description
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
Title
Routine urine test
Description
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
Title
Serum alanine aminotransferase
Description
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
Title
Serum albumin
Description
Serum albumin of healthy volunteers will be measured at two time points: right before injection and 24 hours after treatment.
Time Frame
24 hours
Title
Serum creatinine
Description
Serum creatinine of healthy volunteers will be measured at two time points: right before injection and 24 hours after treatment.
Time Frame
24 hours
Title
Adverse events collection
Description
Adverse events within 5 days after the injection and scanning of healthy volunteers and patients will be followed and assessed.
Time Frame
5 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Li Fang, MD
Phone
86-10-69155502
Email
lifang@pumch.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Zhu Zhaohui, MD, PhD
Phone
86-10-13611093752
Email
13611093752@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhaohui Zhu
Organizational Affiliation
Peking Union Medical College Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Peking Union Medical College Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100730
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhaohui Zhu, MD
Phone
86-10-69154196
Email
13611093752@163.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32517690
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.
Results Reference
derived
PubMed Identifier
26924501
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.
Results Reference
derived

Learn more about this trial

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

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