Biodistribution and Pathophysiology Study of 18F-Fluorodeoxysorbitol (18F-FDS) in Diseased Patients

Study Overview
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Brief Summary
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This study is being performed to see if 18F-FDS is a useful imaging agent for diagnosis of bacterial infections. Position Emission Tomography / computed tomography (CT) scans will be obtained after intravenous injection of 18F-FDS to determine biodistribution and pathophysiology in diseased subjects.

Official Title
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Phase 1 Biodistribution and Pathophysiology Study of 18F-Fluorodeoxysorbitol (18F-FDS)

Conditions
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Enterobacterial Infections, Oncologic Disease, Inflammatory Disease, Invasive Fungal Infections

Intervention / Treatment
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* Combination Product: 18F-FDS PET/CT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female >12 years of age at the time of consent and imaging. Determined by a physician to be stable to participate in the study Subjects with any of the following: Active proven or probable invasive fungal disease OR Confirmed or suspected Enterobacterial infections OR Confirmed inflammatory 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. Exclusion Criteria: 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: Pregnancy Lactating females History of significant renal or hepatobiliary diseases 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 which will exceed 5 rems in the last year.

Ages Eligible for Study
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Minimum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 18F-FDS PET/CT<br>a single intravenous dose of 18F-FDS followed by PET/CT scan. | Combination Product: 18F-FDS PET/CT<br>* 20 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. Data analyses will be performed in a blinded fashion. | 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 analyses will be performed in a blinded fashion. | Up to 3 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PET/CT, 18F-FDS