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

NCT ID: NCT05609552

Last Updated: 2025-12-12

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 10 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-05-22
• Study Completion Date: 2025-10-28

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.

Conditions

Tuberculosis

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

Tuberculosis patients

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

18F-Pretomanid PET/CT

Intervention Type: COMBINATION_PRODUCT

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.

Interventions

18F-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.

Intervention Type: COMBINATION_PRODUCT

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sanjay K Jain, M.D.

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Johns Hopkins Medical Institutions

Baltimore, Maryland, United States

Countries

United States

Other Identifiers

R01HL131829

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB00303845

Identifier Type: -

Identifier Source: org_study_id