Enterobacterial InfectionsNCT05611892
Biodistribution and Pathophysiology Study of 18F-Fluorodeoxysorbitol (18F-FDS) in Diseased Patients
An observational study of Enterobacterial Infections and Oncologic Disease, run by Johns Hopkins University at 1 site in United States.
Trial summary
In this study, the investigators will assess the hypothesis that this new positron emission tomography (PET) radiopharmaceutical, 18F-Fluorodeoxysorbitol (18F-FDS), will specifically localize at sites of Gram-negative bacterial due to Enterobacterales and invasive mold infections (e.g. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Enterobacterial Infections, Oncologic Disease, Inflammatory Disease
- What is being tested?
- 18F-FDS PET/CT
- Type of treatment
- Injection or infusion
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Dec 2022to 28 Oct 2025
- Phase
- Observational
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Males and female members of all races and ethnic groups are eligible for this trial and encouraged to participate
Who may be able to join
- Subjects may be enrolled into this protocol only if all of the following criteria are met:
- Male or female >12 years of age at the time of consent and imaging. No healthy adolescent subjects will be enrolled in the study.
- For inpatients, determined by the attending of record to be stable to participate in the study (will be documented in the research records).
- For invasive mold infections - signs and symptoms clinically compatible with PROVEN or PROBABLE active invasive mold disease as determined by The European Organization for Research and Treatment of Cancer and the Mycoses Study Group Education and Research Consortium (EORTC/MSGERC) consensus definitions:
- PROVEN disease: Biopsy or needle aspiration positive for organism (i.e., hyphae, yeast cells, etc.) on microscopic examination or culture, OR nucleic acid diagnosis (i.e., PCR), OR blood culture.
- PROBABLE disease: POSITIVE galactomannan EIA based on clinically acceptable cutoff as follows:
Show all 15Show fewer
- Single serum or plasma >=1.0
- BAL >=1.0
- Single serum or plasma >=0.7 and BAL fluid >=0.8 CSF >1
- For Enterobacterales infections - clinically compatible illness plus one or more of the following:
- Confirmed (microbiologically, molecular or serological testing) diagnosis of infection at anybody site OR
- clinical and imaging evidence of suspected infection in any body site with confirmation (microbiologically, molecular or serological testing) anticipated within 72 hours of imaging.
- For non-infectious control patients: Subjects with confirmed inflammatory (rheumatoid arthritis, idiopathic pulmonary fibrosis, etc) or oncologic (e.g. localized or metastatic tumors) disease and clinically determined not to have infection.
- Subject is judged by the investigator to have the initiative and means to be compliant with the protocol.
- Subjects or their legal representatives must have the ability to read, understand and provide written informed consent for the initiation of any study related procedures. Adults lacking capacity will not be enrolled in this study.
Who cannot join
- Within 28 or fewer days prior to imaging, a complete blood count with differential, blood comprehensive metabolic panel will be performed. Subjects will be excluded from enrollment if any of the following apply:
- Reported pregnancy or pregnancy as determined by positive or indeterminate serum human chorionic gonadotrophin (hCG) at screening and positive urine hCG prior to radiopharmaceutical dosing.
- Lactating females
- History of significant renal or hepatobiliary diseases (Serum creatinine > 3 times the upper limit of normal or Total bilirubin > 3 times the upper limit of normal or Liver Transaminases > 5 times the upper limit of normal)
- Inadequate venous access
- Administered a radioisotope within 5 physical half-lives as part of a research study prior to study enrollment
- Subject has been treated with an investigational drug / biologic / therapeutic device within 30 days prior to study radiotracer administration
- Determined to have prior (external) radiation exposure from research studies which will exceed RDRC annual radiation exposure limit of 5 rems.
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins Medical Institutions
Baltimore, Maryland, 21218
About this study
Official title: Phase 1 Biodistribution and Pathophysiology Study of 18F-Fluorodeoxysorbitol (18F-FDS)
In this study, the investigators will assess the hypothesis that this new positron emission tomography (PET) radiopharmaceutical, 18F-Fluorodeoxysorbitol (18F-FDS), will specifically localize at sites of Gram-negative bacterial due to Enterobacterales and invasive mold infections (e.g. invasive aspergillosis/mucormycosis).
- Conditions
- Enterobacterial Infections, Oncologic Disease, Inflammatory Disease, Invasive Fungal Infections
- Being tested
- 18F-FDS PET/CT
- Keywords
- PET/CT, 18F-FDS
- Medical subject headings
- Enterobacteriaceae Infections, Invasive Fungal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F-FDS PET/CTCombination product
20 millicurie (mCi) of 18F-FDS in adult patient age group and 2.5 mCi in children (age 12-18 years old) followed by a PET/CT scan.
| Study group | Role | What they receive |
|---|---|---|
| 18F-FDS PET/CT | a single intravenous dose of 18F-FDS followed by PET/CT scan. Receives: Combination Product: 18F-FDS PET/CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biodistribution of 18F-FDS in diseased subjects
Reconstruction of the PET data will be performed by means of iterative reconstruction (IR) by the ordered subset-expectation-maximization method with CT attenuation correction. Volumes of interest will be drawn on fused PET and CT images across different body compartments and comparison.
Measured: Up to 3 hours
Pathophysiology of 18F-FDS in diseased subjects
Reconstruction of the PET data will be performed by means of iterative reconstruction by the ordered subset-expectation-maximization method with CT attenuation correction. Volumes of interest will be drawn on fused PET and CT images. Data will be presented as target-to-nontarget ratio (TNT), defined as the ratio of the PET signal at the sites of pathology to the unaffected sites of the same tissue.
Measured: Up to 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2022
- Study start22 Dec 2022
- Primary completion28 Oct 2025
- Study completion28 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Enterobacterial InfectionsStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Sponsor
- Investigators
- Sanjay K Jain, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05611892
- Sponsor's protocol ID
- IRB00097331
- Status last verified
- Dec 2025
- First submitted
- 3 Nov 2022
- Last updated
- 12 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Biodistribution and Pathophysiology Study of 18F-Fluorodeoxysorbitol (18F-FDS)
- ClinicalTrials.gov ID
- NCT05611892
- Acronym / sponsor ID
- IRB00097331
- Conditions
- Enterobacterial Infections, Oncologic Disease, Inflammatory Disease, Invasive Fungal Infections
- Keywords
- PET/CT, 18F-FDS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- 22 Dec 2022 (actual)
- Primary completion
- 28 Oct 2025 (actual)
- Study completion
- 28 Oct 2025 (actual)
- First posted
- 10 Nov 2022 (actual)
- 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.
In this study, the investigators will assess the hypothesis that this new positron emission tomography (PET) radiopharmaceutical, 18F-Fluorodeoxysorbitol (18F-FDS), will specifically localize at sites of Gram-negative bacterial due to Enterobacterales and invasive mold infections (e.g. invasive aspergillosis/mucormycosis).
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 18F-FDS PET/CT | – | Combination Product: 18F-FDS PET/CTa single intravenous dose of 18F-FDS followed by PET/CT scan. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Males and female members of all races and ethnic groups are eligible for this trial and encouraged to participate
Key inclusion criteria (15 listed)
- Subjects may be enrolled into this protocol only if all of the following criteria are met:
- Male or female >12 years of age at the time of consent and imaging. No healthy adolescent subjects will be enrolled in the study.
- For inpatients, determined by the attending of record to be stable to participate in the study (will be documented in the research records).
- For invasive mold infections - signs and symptoms clinically compatible with PROVEN or PROBABLE active invasive mold disease as determined by The European Organization for Research and Treatment of Cancer and the Mycoses Study Group Education and Research Consortium (EORTC/MSGERC) consensus definitions:
- PROVEN disease: Biopsy or needle aspiration positive for organism (i.e., hyphae, yeast cells, etc.) on microscopic examination or culture, OR nucleic acid diagnosis (i.e., PCR), OR blood culture.
Key exclusion criteria (8 listed)
- Within 28 or fewer days prior to imaging, a complete blood count with differential, blood comprehensive metabolic panel will be performed. Subjects will be excluded from enrollment if any of the following apply:
- Reported pregnancy or pregnancy as determined by positive or indeterminate serum human chorionic gonadotrophin (hCG) at screening and positive urine hCG prior to radiopharmaceutical dosing.
- Lactating females
- History of significant renal or hepatobiliary diseases (Serum creatinine > 3 times the upper limit of normal or Total bilirubin > 3 times the upper limit of normal or Liver Transaminases > 5 times the upper limit of normal)
- Inadequate venous access
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-FDS PET/CT20 millicurie (mCi) of 18F-FDS in adult patient age group and 2.5 mCi in children (age 12-18 years old) followed by a PET/CT scan. | Combination product | 18F-FDS PET/CT |
Primary outcome
Biodistribution of 18F-FDS in diseased subjects
Time frame: Up to 3 hours
Reconstruction of the PET data will be performed by means of iterative reconstruction (IR) by the ordered subset-expectation-maximization method with CT attenuation correction. Volumes of interest will be drawn on fused PET and CT images across different body compartments and comparison.
Pathophysiology of 18F-FDS in diseased subjects
Time frame: Up to 3 hours
Reconstruction of the PET data will be performed by means of iterative reconstruction by the ordered subset-expectation-maximization method with CT attenuation correction. Volumes of interest will be drawn on fused PET and CT images. Data will be presented as target-to-nontarget ratio (TNT), defined as the ratio of the PET signal at the sites of pathology to the unaffected sites of the same tissue.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2025.
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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.
Sanjay K Jain, MD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Enterobacterial Infections and Oncologic Disease, run by Johns Hopkins University at 1 site in United States.
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 15 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: finished, as of the sponsor's last update on 12 Dec 2025. 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 United States. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biodistribution of 18F-FDS in diseased subjects (time frame: Up to 3 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Dec 2025.