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

Inclusion criteria:

Subjects may be enrolled into this protocol only if all of the following criteria are met:

1. Male or female >12 years of age at the time of consent and imaging. No healthyadolescent subjects will be enrolled in the study.

2. For inpatients, determined by the attending of record to be stable to participate inthe study (will be documented in the research records).

3. For invasive mold infections - signs and symptoms clinically compatible with PROVENor PROBABLE active invasive mold disease as determined by The European Organizationfor Research and Treatment of Cancer and the Mycoses Study Group Education andResearch 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 cutoffas follows:

4. Single serum or plasma >=1.0

5. BAL >=1.0

6. Single serum or plasma >=0.7 and BAL fluid >=0.8 CSF >1

7. For Enterobacterales infections - clinically compatible illness plus one or more ofthe following:

8. Confirmed (microbiologically, molecular or serological testing) diagnosis ofinfection at anybody site OR

9. clinical and imaging evidence of suspected infection in any body site withconfirmation (microbiologically, molecular or serological testing) anticipatedwithin 72 hours of imaging.

10. 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 haveinfection.

11. Subject is judged by the investigator to have the initiative and means to becompliant with the protocol.

12. Subjects or their legal representatives must have the ability to read, understandand provide written informed consent for the initiation of any study relatedprocedures. Adults lacking capacity will not be enrolled in this study.

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:

1. Reported pregnancy or pregnancy as determined by positive or indeterminate serumhuman chorionic gonadotrophin (hCG) at screening and positive urine hCG prior toradiopharmaceutical dosing.

2. Lactating females

3. History of significant renal or hepatobiliary diseases (Serum creatinine > 3 timesthe upper limit of normal or Total bilirubin > 3 times the upper limit of normal orLiver Transaminases > 5 times the upper limit of normal)

4. Inadequate venous access

5. Administered a radioisotope within 5 physical half-lives as part of a research studyprior to study enrollment

6. Subject has been treated with an investigational drug / biologic / therapeuticdevice within 30 days prior to study radiotracer administration

7. Determined to have prior (external) radiation exposure from research studies whichwill exceed RDRC annual radiation exposure limit of 5 rems.