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

Study Overview
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Brief Summary
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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
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Biodistribution and Pharmacokinetics of Pretomanid in Tuberculosis Patients Using 18F-Pretomanid PET

Conditions
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Tuberculosis

Intervention / Treatment
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* Combination Product: 18F-Pretomanid PET/CT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female ≥18 years of age at the time of consent and imaging Healthy subjects OR Subjects with confirmed tuberculosis OR high suspicion of active tuberculosis by treating physician. For TB patients: Imaging evidence of suspected tuberculosis infection involving the lung, and possible additional other sites of involvement. For TB patients: After TB diagnosis is confirmed, patients will be eligible to participate up to 6 weeks after starting TB treatment. 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. Screening clinical laboratory values must be within normal limits or judged not clinically significant by the investigator. Women of child-bearing potential (WOCBP) must have a negative serum or urine pregnancy test within 24 hours prior to the radiotracer administration. 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: Inadequate venous access Any medical condition that in the judgment of the investigator would make the patient inappropriate for entry into this study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Tuberculosis patients<br>Patients with confirmed TB [culture confirmed or positive by genotypic testing with GeneXpert, Accuporobe, etc.] by genotype and/or culture testing positive for M. tuberculosis | Combination Product: 18F-Pretomanid PET/CT<br>* A bolus of less than or equal to 10 mCi (370 MBq) of 18F-pretomanid will be injected into the intravenous line by slow IV push. Immediately after administration of 18F-pretomanid, dynamic PET acquisition will take place.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biodistribution of 18F-pretomanid | Exposures in infected sites (pneumonia, cavitary lesions, etc.) will compared with the uninfected compartments. Standard units such as area under the curve (AUC) or AUC ratios will be utilized. | Up to 4 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PET/CT, Pretomanid