Tuberculosis
Conditions
Keywords
PET/CT, Pretomanid
Brief summary
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.
Interventions
COMBINATION_PRODUCT18F-Pretomanid PET/CT
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.
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
Johns Hopkins University
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Biodistribution of 18F-pretomanid | Up to 4 hours | 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. |
Countries
United States
Outcome results
None listed