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NOT YET RECRUITING
NCT07859800
NA

Positron Emission Tomography and Organ-Specific Changes in Participants Co-Enrolled in NIH Studies of Plasmodium Vivax Controlled Human Malaria Infection

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

View on ClinicalTrials.gov

Summary

Background: Malaria is a serious disease caused by parasites spread by mosquitoes. To better diagnose and treat malaria, researchers need to learn more about where the parasites go when they enter a person's body. They want to see if they can locate the malaria parasites in the body using imaging scans. Objective: To learn whether imaging scans can locate parasites in people with malaria. Eligibility: Healthy people aged 18 to 54 years. They must be enrolled in protocol IRB001970 or IRB002627 for controlled malaria infection. Design: Participants will be screened. They will have blood drawn and a physical exam, including an abdominal exam to check the size of their spleen. Participants for this study will have 2 or 3 positron emission tomography/computed tomography (PET/CT) scans: The first will be about 3 days before they are deliberately infected with malaria for a different study. The second will be about 13 days later, while they have the disease. The third scan is optional; it will be done about 3 and 1/2 weeks after the second scan. For each scan, participants will receive a radioactive tracer called fluorodeoxyglucose (FDG). FDG will be injected through a tube inserted into a vein. They will lie on a table that slides through a doughnut-shaped machine. PET/CT uses x-rays to create images of the inside of the body. All participants will have a follow-up visit about 3 and 1/2 weeks after the second scan. The blood draw and physical exam will be repeated. This visit may be combined with the third scan for those who choose it.

Key Details

Gender

All

Age Range

18 Years - 54 Years

Study Type

INTERVENTIONAL

Enrollment

45

Start Date

2026-10-14

Completion Date

2030-11-01

Last Updated

2026-10-09

Healthy Volunteers

No

Interventions

DIAGNOSTIC_TEST

18F-fluorodeoxyglucose-positron emission tomography/computed tomography scan

Participants are co-enrolled in a Plasmodium vivax challenge model protocol at the NIH Clinical Center. These participants will undergo up to 3 18F-fluorodeoxyglucose-positron emission tomography (FDG-PET)/computed tomography (CT) scans of their chest, abdomen, and pelvis. PET/CT scans will occur at baseline (before controlled human malaria infection (CHMI) inoculation), and at the expected time of peak parasitemia. Participants may have an optional 3rd PET/CT scan at day 34 after the CHMI inoculation. FDG uptake will be used to visualize organ-specific changes as a result of malaria infection.

Locations (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, United States