COMPLETED

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

Conditions

Renal Excretion Bacterial Infections Inflammatory Disease Oncologic Disease PET/CT Probenecid 11C-PABA

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

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

Quick Facts

Study Start:2023-12-22

Study Completion:2025-11-08

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT05611905

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Not specified

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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. 3. For subjects with infections: 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.	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

Inclusion Criteria

Exclusion 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.
3. For subjects with infections:
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.

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

Contacts and Locations

Principal Investigator

Sanjay K Jain, MD

PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Study Locations (Sites)

Johns Hopkins Medical Institutions

Baltimore, Maryland, 21218

United States

Collaborators and Investigators

Sponsor: Johns Hopkins University

Sanjay K Jain, MD, PRINCIPAL_INVESTIGATOR, Johns Hopkins University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-12-22

Study Completion Date2025-11-08

Study Record Updates

Study Start Date2023-12-22

Study Completion Date2025-11-08

Terms related to this study

Keywords Provided by Researchers

PET/CT
Probenecid
11C-PABA

Additional Relevant MeSH Terms

Renal Excretion
Bacterial Infections
Inflammatory Disease
Oncologic Disease