Biodistribution and Pathophysiology Study of 18F-Fluorodeoxysorbitol (18F-FDS) in Diseased Patients (NCT05611892) | Clinical Trial Compass
CompletedNot Applicable
Biodistribution and Pathophysiology Study of 18F-Fluorodeoxysorbitol (18F-FDS) in Diseased Patients
United States16 participantsStarted 2022-12-22
Plain-language 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. invasive aspergillosis/mucormycosis).
Who can participate
Age range12 Years
SexALL
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Inclusion criteria
✓. 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:
✓. 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
Exclusion criteria
✕. 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)