Biodistribution and Pharmacokinetics of Pretomanid in Tuberculosis Patients Using 18F-Pretomanid PET

Description

This is an observational study that will examine the pretomanid pharmacokinetics (PK) in tuberculosis (TB) patients. Dynamic 18F-pretomanid PET/CT will be performed after intravenous injection of 18F-pretomanid to determine multi-compartment, noninvasive determination of pretomanid PK in TB patients.

Conditions

Tuberculosis

Study Overview

Study Details

Study overview

This is an observational study that will examine the pretomanid pharmacokinetics (PK) in tuberculosis (TB) patients. Dynamic 18F-pretomanid PET/CT will be performed after intravenous injection of 18F-pretomanid to determine multi-compartment, noninvasive determination of pretomanid PK in TB patients.

Biodistribution and Pharmacokinetics of Pretomanid in Tuberculosis Patients Using 18F-Pretomanid PET

Biodistribution and Pharmacokinetics of Pretomanid in Tuberculosis Patients Using 18F-Pretomanid PET

Condition
Tuberculosis
Intervention / Treatment

-

Contacts and Locations

Baltimore

Johns Hopkins Medical Institutions, Baltimore, Maryland, United States, 21218

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Male or female ≥18 years of age at the time of consent and imaging
  • 2. Healthy subjects OR Subjects with confirmed tuberculosis OR high suspicion of active tuberculosis by treating physician.
  • 3. For TB patients: Imaging evidence of suspected tuberculosis infection involving the lung, and possible additional other sites of involvement.
  • 4. For TB patients: After TB diagnosis is confirmed, patients will be eligible to participate up to 6 weeks after starting TB treatment.
  • 5. Subject is willing to give written informed consent. Subject is willing and able to comply with the protocol for the duration of the study including undergoing scheduled visits and study procedures.
  • 6. Screening clinical laboratory values must be within normal limits or judged not clinically significant by the investigator.
  • 7. Women of child-bearing potential (WOCBP) must have a negative serum or urine pregnancy test within 24 hours prior to the radiotracer administration.
  • 8. Patients or their legal representatives must have the ability to read, understand and provide written informed consent for the initiation of any study-related procedures.
  • 1. Inadequate venous access
  • 2. Any medical condition that in the judgment of the investigator would make the patient inappropriate for entry into this study

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Johns Hopkins University,

Sanjay K Jain, M.D., PRINCIPAL_INVESTIGATOR, Johns Hopkins University

Study Record Dates

2026-02-01