Phase 1 Biodistribution and Pathophysiology Study of 11C-para-aminobenzoic Acid (11C-PABA)
Overview
- Phase
- Not Applicable
- Intervention
- 11C-para-aminobenzoic acid PET/CT
- Conditions
- Renal Excretion
- Sponsor
- Johns Hopkins University
- Enrollment
- 13
- Locations
- 1
- Primary Endpoint
- Pathophysiology of 11C-PABA in diseased subjects
- Status
- Completed
- Last Updated
- 4 months ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Male or female ≥18 years of age at the time of consent and imaging.
- •Healthy subjects OR those with confirmed (microbiologically, molecular or serological testing) diagnosis of infection at any body 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.
- •OR 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.
- •For subjects with infections:
- •Non mycobacterium tuberculosis infections: received no more than 7 days of effective antibiotic treatment, as judged by the attending and/or principal investigator.
- •OR Mycobacterium tuberculosis or mycobacteroides infections: received no more than 4 weeks of effective treatment. Infection confirmed by positive culture or molecular testing.
- •For inpatients, determined by the attending of record to be stable to participate in the study (will be documented in the research records).
- •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.
- •Exclusion criteria:
Exclusion Criteria
- Not provided
Arms & Interventions
11C-para-aminobenzoic acid PET/CT
Intervention: 11C-para-aminobenzoic acid PET/CT
11C-para-aminobenzoic acid PET/CT
Intervention: Probenecid
Outcomes
Primary Outcomes
Pathophysiology of 11C-PABA 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 (OSEM) method with CT attenuation correction.
Biodistribution of 11C-PABA 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 (OSEM) method with CT attenuation correction.