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

Launched by JOHNS HOPKINS UNIVERSITY · Nov 1, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a medication called pretomanid in patients with tuberculosis (TB). Specifically, the researchers want to understand how pretomanid moves and works in the body using a special imaging technique called 18F-pretomanid PET/CT scans. This study is observational, meaning that researchers will watch and analyze how the medication behaves in TB patients after they receive an intravenous injection of the drug.

To participate in this trial, individuals must be at least 18 years old and either healthy or diagnosed with tuberculosis. For those with TB, there should be imaging evidence of the infection, and they must be within six weeks of starting TB treatment. Participants will need to provide written consent and comply with study procedures. Throughout the trial, participants can expect to undergo scheduled visits and imaging tests to gather important information about how pretomanid works in their bodies. It’s important to note that women who can become pregnant will need to take a pregnancy test before receiving the treatment. This study aims to provide valuable insights that could help improve TB treatment in the future.

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 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.
• Exclusion Criteria:
• • 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