RECRUITING

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

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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

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.

Official Title

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

Quick Facts

Study Start:2023-05-22

Study Completion:2026-02-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05609552

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:Yes

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 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

Inclusion Criteria

Exclusion 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

Contacts and Locations

Study Contact

Sanjay K Jain, M.D.

CONTACT

(410)502-8241

sjain5@jhmi.edu

Principal Investigator

Sanjay K Jain, M.D.

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, M.D., 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 Date2023-05-22

Study Completion Date2026-02-01

Study Record Updates

Study Start Date2023-05-22

Study Completion Date2026-02-01

Terms related to this study

Keywords Provided by Researchers

PET/CT
Pretomanid

Additional Relevant MeSH Terms

Tuberculosis