Enterobacteriaceae InfectionsEarly Phase 1NCT02450942
18F-FDS PET/CT in Healthy Volunteers and Patients With Suspected Infection
A Early Phase 1 study testing 18F-FDS in people with Enterobacteriaceae Infections, run by Peking Union Medical College Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Enterobacteriaceae Infections
- What is being tested?
- 18F-FDS
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- Jan 2015to Mar 2018
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
Zhaohui Zhu, MD, 86-10-69154196, 13611093752@163.com
About this study
Official title: Radiation Dosimetry, Plasma Pharmacokinetics, Biodistribution, Safety and Diagnostic Performance of 18F-FDS PET/CT in Healthy Volunteers and Patients With Suspected Infection
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.
Read the 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.
- Conditions
- Enterobacteriaceae Infections
- Being tested
- 18F-FDS
- Medical subject headings
- Enterobacteriaceae Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F-FDSDrug
Also called 2-[18F]-fluorodeoxysorbitol
18F-FDS were intravenously injected into the patients 1 h before the PET/CT scans
| Study group | Role | What they receive |
|---|---|---|
| 18F-FDS injection and PET/CT scan | Experimental | The patients were intravenously injected with 18F-FDS and underwent PET/CT scan 1 h after the injection. Receives: Drug: 18F-FDS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: One year
Secondary outcomes (10)
Blood pressure
Blood pressure of healthy volunteers will be measured at three time points: right before injection, after scanning, and 24 hours after treatment.
Measured: 24 hours
Pulse
Pulse will be measured at three time points for each healthy volunteer: right before injection, after scanning, and 24 hours after treatment.
Measured: 24 hours
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.
Measured: 24 hours
Temperature
Temperature will be measured at three time points for each healthy volunteer: right before injection, after scanning, and 24 hours after treatment.
Measured: 24 hours
Routine blood test
Routine blood test of healthy volunteers will be measured at two time points: right before injection and 24 hours after treatment.
Measured: 24 hours
Routine urine test
Routine urine test of healthy volunteers will be measured at two time points: right before injection and 24 hours after treatment.
Measured: 24 hours
Serum alanine aminotransferase
Serum alanine aminotransferase of healthy volunteers will be measured at two time points: right before injection and 24 hours after treatment.
Measured: 24 hours
Serum albumin
Serum albumin of healthy volunteers will be measured at two time points: right before injection and 24 hours after treatment.
Measured: 24 hours
Serum creatinine
Serum creatinine of healthy volunteers will be measured at two time points: right before injection and 24 hours after treatment.
Measured: 24 hours
Adverse events collection
Adverse events within 5 days after the injection and scanning of healthy volunteers and patients will be followed and assessed.
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2015 (estimated)
- Study startJan 2015
- Primary completionJan 2018 (estimated)
- Study completionMar 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Enterobacteriaceae InfectionsStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zhaohui Zhu, Study chair, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02450942
- Sponsor's protocol ID
- PUMCHNM08
- Status last verified
- May 2015
- First submitted
- 13 May 2015
- Last updated
- 7 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
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.
PubMed 32517690Yao 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.
PubMed 26924501
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiation Dosimetry, Plasma Pharmacokinetics, Biodistribution, Safety and Diagnostic Performance of 18F-FDS PET/CT in Healthy Volunteers and Patients With Suspected Infection
- ClinicalTrials.gov ID
- NCT02450942
- Acronym / sponsor ID
- PUMCHNM08
- Conditions
- Enterobacteriaceae Infections
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Jan 2018 (estimated)
- Study completion
- Mar 2018 (estimated)
- First posted
- 21 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 18F-FDS injection and PET/CT scan | Experimental | Drug: 18F-FDSThe patients were intravenously injected with 18F-FDS and underwent PET/CT scan 1 h after the injection. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Healthy volunteers:
- o Males and females, ≥18 years old
- Infectious patients:
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 18F-FDSAlso: 2-[18F]-fluorodeoxysorbitol18F-FDS were intravenously injected into the patients 1 h before the PET/CT scans | Drug | 18F-FDS injection and PET/CT scan |
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.
10 secondary outcomes
Blood pressure
Time frame: 24 hours
Pulse
Time frame: 24 hours
Respiration frequency
Time frame: 24 hours
Temperature
Time frame: 24 hours
Routine blood test
Time frame: 24 hours
Routine urine test
Time frame: 24 hours
Serum alanine aminotransferase
Time frame: 24 hours
Serum albumin
Time frame: 24 hours
Serum creatinine
Time frame: 24 hours
Adverse events collection
Time frame: 5 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2017.
- Derived from this study: PubMed 32517690Kong 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.
- Derived from this study: PubMed 26924501Yao 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhaohui Zhu study chair
Peking Union Medical College Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing 18F-FDS in people with Enterobacteriaceae Infections, run by Peking Union Medical College Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Li Fang, MD (86-10-69155502, lifang@pumch.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual and semiquantitative assessment of lesions and biodistribution (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02450942, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2017.