Biodistribution and Pathophysiology Study of 11C-para-aminobenzoic Acid

Study Overview
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Brief Summary
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The investigators will perform radionuclide PET scans in subjects with infectious diseases to assess whether radio-labeled PABA (11C-PABA) is effective for infection imaging. Tomographic imaging can be used to evaluate disease processes deep within the body, noninvasively and relatively rapidly. The goal is to see if this imaging technique can help differentiate infections from non-infectious processes and also provide information on the causative bacterial class.

Official Title
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Phase 1 Biodistribution and Pathophysiology Study of 11C-para-aminobenzoic Acid (11C-PABA)

Conditions
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Renal Excretion, Bacterial Infections, Inflammatory Disease, Oncologic Disease

Intervention / Treatment
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* Combination Product: 11C-para-aminobenzoic acid PET/CT
* Drug: Probenecid


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female ≥18 years of age at the time of consent and imaging Those with confirmed diagnosis of infection at any body site OR clinical and imaging evidence of suspected infection in any body site OR confirmed inflammatory oncologic disease. Assessed to be in stable condition to participate in the study 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 Exclusion Criteria: Pregnancy Lactating females History of significant renal or hepatobiliary diseases Inadequate venous access Administered a radioisotope within 5 physical half-lives prior to study enrollment Treated with an investigational drug / biologic / therapeutic device within 30 days prior to study Determined to have prior (external) radiation exposure of 5 rems in past year

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 11C-para-aminobenzoic acid PET/CT<br> | Combination Product: 11C-para-aminobenzoic acid PET/CT<br>* A bolus of 20 mCi of 11C-PABA followed by PET/CT<br>Drug: Probenecid<br>* Oral dose of 500 mg (tablet) 2 hours before IV dose of 11C-PABA will be administered.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pathophysiology of 11C-PABA in diseased subjects | Reconstruction of the PET data will be performed by means of iterative reconstruction (IR) by the ordered subset-expectation-maximization (OSEM) method with CT attenuation correction. | Up to 3 hours | 
| Biodistribution of 11C-PABA in diseased subjects | Reconstruction of the PET data will be performed by means of iterative reconstruction (IR) by the ordered subset-expectation-maximization (OSEM) method with CT attenuation correction. | 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, Probenecid, 11C-PABA