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

Launched by JOHNS HOPKINS UNIVERSITY · Nov 3, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new imaging technique using a special substance called 11C-para-aminobenzoic Acid (11C-PABA) to help doctors see infections in the body. The goal is to find out if this method can help them tell the difference between infections and other health issues, and to identify the type of bacteria causing the infection. Participants will undergo PET scans, which are non-invasive imaging tests that allow doctors to see what's happening inside the body quickly.

To be eligible for this study, you need to be at least 18 years old and either healthy or have a confirmed infection, inflammatory disease, or cancer. If you have an infection, you should have received limited treatment with antibiotics before the imaging. Pregnant or breastfeeding individuals, and those with certain health conditions like severe hypertension or diabetes, cannot participate. During the study, participants can expect to have their health monitored and be asked to provide informed consent before any procedures. This trial is currently recruiting participants, and it aims to improve how infections are diagnosed and treated.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Male or female ≥18 years of age at the time of consent and imaging.
• • 2. 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.
• 3. 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.
• • 4. For inpatients, determined by the attending of record to be stable to participate in the study (will be documented in the research records).
• • 5. Subject is judged by the investigator to have the initiative and means to be compliant with the protocol.
• • 6. 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:
• 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 serum human chorionic gonadotrophin (hCG) at screening and positive urine hCG prior to radiopharmaceutical dosing.
• • 2. Lactating females.
• • 3. Inadequate venous access.
• • 4. Screening clinical laboratory values must be within normal limits or judged not clinically significant by the principal investigator.
• • 5. Administered a radioisotope within 5 physical half-lives prior to study enrollment.
• • 6. Subject has been treated with an investigational drug / biologic / therapeutic device within 30 days prior to study radiotracer administration.
• • 7. Determined to have prior (external) radiation exposure which will exceed RDRC annual radiation exposure limit of 5 rems.
• 8. For patients undergoing renal imaging they will be excluded if any of the following conditions exist:
• • Hypertension
• • Diabetes mellitus type I or II
• • Body mass index less than 18.5 kg/m2 or higher than 30 kg/m2
• • Family history of renal disease
• • Urinary tract infection in the prior 6 months