Renal ExcretionNCT05611905
Biodistribution and Pathophysiology Study of 11C-para-aminobenzoic Acid
An observational study of Renal Excretion and Bacterial Infections, run by Johns Hopkins University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Excretion, Bacterial Infections, Inflammatory Disease
- What is being tested?
- 11C-para-aminobenzoic acid PET/CT and Probenecid
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Dec 2023to 8 Nov 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Patients with bacterial infections or non-infectious processes such as inflammatory / oncologic diseases will be enrolled. Males and female members of all races and ethnic groups are eligible for this trial and encouraged to participate.
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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:
- 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.
- Inadequate venous access.
- Screening clinical laboratory values must be within normal limits or judged not clinically significant by the principal investigator.
- Administered a radioisotope within 5 physical half-lives prior to study enrollment.
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- Subject has been treated with an investigational drug / biologic / therapeutic device within 30 days prior to study radiotracer administration.
- Determined to have prior (external) radiation exposure which will exceed RDRC annual radiation exposure limit of 5 rems.
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins Medical Institutions
Baltimore, Maryland, 21218
About this study
Official title: Phase 1 Biodistribution and Pathophysiology Study of 11C-para-aminobenzoic Acid (11C-PABA)
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.
- Being tested
- 11C-para-aminobenzoic acid PET/CT, Probenecid
- Keywords
- PET/CT, Probenecid, 11C-PABA
- Medical subject headings
- Bacterial Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
11C-para-aminobenzoic acid PET/CTCombination product
A bolus of 20 mCi of 11C-PABA followed by PET/CT
ProbenecidDrug
Oral dose of 500 mg (tablet) 2 hours before IV dose of 11C-PABA will be administered.
| Study group | Role | What they receive |
|---|---|---|
| 11C-para-aminobenzoic acid PET/CT | Not described Receives: Combination Product: 11C-para-aminobenzoic acid PET/CT; Drug: Probenecid |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Up to 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2022
- Study start22 Dec 2023
- Primary completion8 Nov 2025
- Study completion8 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Renal ExcretionStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Sanjay K Jain, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05611905
- Sponsor's protocol ID
- IRB00179210
- Other IDs
- R01HL131829
- Status last verified
- Dec 2025
- First submitted
- 3 Nov 2022
- Last updated
- 12 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Masias-Leon Y, Ruiz-Gonzalez CE, Nino-Meza OJ, Singh M, Sarhan MO, Chen X, Flavahan K, Kronenberg A, Tucker EW, Freundlich JS, Lodge MA, Carroll LS, Parrish N, Lechtzin N, Jain SK. Dynamic 11C-Para-Aminobenzoic Acid Positron Emission Tomography/Computed Tomography for Visualizing Pulmonary Mycobacteroides abscessus Infections. Am J Respir Crit Care Med. 2025 Jul;211(7):1253-1263. doi: 10.1164/rccm.202409-1792OC.
PubMed 40153540
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Biodistribution and Pathophysiology Study of 11C-para-aminobenzoic Acid (11C-PABA)
- ClinicalTrials.gov ID
- NCT05611905
- Acronym / sponsor ID
- IRB00179210
- Keywords
- PET/CT, Probenecid, 11C-PABA
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 22 Dec 2023 (actual)
- Primary completion
- 8 Nov 2025 (actual)
- Study completion
- 8 Nov 2025 (actual)
- First posted
- 10 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 11C-para-aminobenzoic acid PET/CT | – | Combination Product: 11C-para-aminobenzoic acid PET/CT, Drug: Probenecid |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with bacterial infections or non-infectious processes such as inflammatory / oncologic diseases will be enrolled. Males and female members of all races and ethnic groups are eligible for this trial and encouraged to participate.
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (14 listed)
- 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:
- 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.
- Inadequate venous access.
- Screening clinical laboratory values must be within normal limits or judged not clinically significant by the principal investigator.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 11C-para-aminobenzoic acid PET/CTA bolus of 20 mCi of 11C-PABA followed by PET/CT | Combination product | 11C-para-aminobenzoic acid PET/CT |
| ProbenecidOral dose of 500 mg (tablet) 2 hours before IV dose of 11C-PABA will be administered. | Drug | 11C-para-aminobenzoic acid PET/CT |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2025.
- Derived from this study: PubMed 40153540Masias-Leon Y, Ruiz-Gonzalez CE, Nino-Meza OJ, Singh M, Sarhan MO, Chen X, Flavahan K, Kronenberg A, Tucker EW, Freundlich JS, Lodge MA, Carroll LS, Parrish N, Lechtzin N, Jain SK. Dynamic 11C-Para-Aminobenzoic Acid Positron Emission Tomography/Computed Tomography for Visualizing Pulmonary Mycobacteroides abscessus Infections. Am J Respir Crit Care Med. 2025 Jul;211(7):1253-1263. doi: 10.1164/rccm.202409-1792OC.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sanjay K Jain, MD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Renal Excretion and Bacterial Infections, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathophysiology of 11C-PABA in diseased subjects (time frame: Up to 3 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05611905, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2025.