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

NCT ID: NCT05611905

Last Updated: 2025-12-12

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 13 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-12-22
• Study Completion Date: 2025-11-08

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.

Conditions

Renal Excretion; Bacterial Infections; Inflammatory Disease; Oncologic Disease

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

11C-para-aminobenzoic acid PET/CT

11C-para-aminobenzoic acid PET/CT

Intervention Type: COMBINATION_PRODUCT

A bolus of 20 mCi of 11C-PABA followed by PET/CT

Probenecid

Intervention Type: DRUG

Oral dose of 500 mg (tablet) 2 hours before IV dose of 11C-PABA will be administered.

Interventions

11C-para-aminobenzoic acid PET/CT

A bolus of 20 mCi of 11C-PABA followed by PET/CT

Intervention Type: COMBINATION_PRODUCT

Probenecid

Oral dose of 500 mg (tablet) 2 hours before IV dose of 11C-PABA will be administered.

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sanjay K Jain, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Johns Hopkins Medical Institutions

Baltimore, Maryland, United States

Countries

United States

Other Identifiers

R01HL131829

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB00179210

Identifier Type: -

Identifier Source: org_study_id