- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02450942
18F-FDS PET/CT in Healthy Volunteers and Patients With Suspected Infection
Radiation Dosimetry, Plasma Pharmacokinetics, Biodistribution, Safety and Diagnostic Performance of 18F-FDS PET/CT in Healthy Volunteers and Patients With Suspected Infection
Study Overview
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.
Study Type
Enrollment (Anticipated)
Phase
- Early Phase 1
Contacts and Locations
Study Contact
- Name: Li Fang, MD
- Phone Number: 86-10-69155502
- Email: lifang@pumch.cn
Study Contact Backup
- Name: Zhu Zhaohui, MD, PhD
- Phone Number: 86-10-13611093752
- Email: 13611093752@163.com
Study Locations
-
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Beijing
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Beijing, Beijing, China, 100730
- Recruiting
- Peking Union Medical College Hospital
-
Contact:
- Zhaohui Zhu, MD
- Phone Number: 86-10-69154196
- Email: 13611093752@163.com
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: DIAGNOSTIC
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: 18F-FDS injection and PET/CT scan
The patients were intravenously injected with 18F-FDS and underwent PET/CT scan 1 h after the injection.
|
18F-FDS were intravenously injected into the patients 1 h before the PET/CT scans
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
One year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
24 hours
|
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.
|
24 hours
|
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.
|
24 hours
|
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.
|
24 hours
|
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.
|
24 hours
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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.
|
24 hours
|
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.
|
24 hours
|
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.
|
24 hours
|
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.
|
24 hours
|
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.
|
5 days
|
Collaborators and Investigators
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PUMCHNM08
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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