NCT05889286

F18-MHF: Orthopedic Implants-Associated Infection Detection

Phase II Investigation of [F-18]MHF as a PET Tracer to Detect Orthopedic Implants-associated Infection

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 30 (estimated)
• Sponsor: Emory University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

Following intravenous injection of \[F-18\]MHF as a bolus, dynamic PET imaging of the lower limbs will be acquired for approximately 90 minutes. The acquired images will be processed and viewed on a MIMVista or similar workstation. The uptake pattern of \[F-18\]MHF around infected orthopedic knee implant will be determined and compared with its uptake pattern around non-infected knee implants. This study will look at how \[18F\]MHF goes into normal knee replacements and those with suspected infection.

Detailed description

This is a study that will test a compound (chemical substance) that has a small amount of radioactivity attached to it. This substance has a natural tendency to go to bacterial infections. The substance is called \[18F\]MHF and it is given in the form of an injection into a vein. After the substance reaches the infected body region, scans called PET or Positron Emission Tomography, are done. This is similar to having CAT scans or x-rays. Usually a compound called \[18\]FDG is used for PET scans to detect bacterial infections but this substance can't distinguish between bacterial infections and inflammation. This substance called \[18F\]MHF does not go to inflamed tissue and may allow bacterial infections to be seen better. This study will look at how \[18F\]MHF goes into normal knee replacements and those with suspected infection. This will hopefully lead to the development of better imaging techniques to look at bacterial infections. \[18F\]MHF is approved by the FDA (Food and Drug Administration) for research.

Conditions

• Knee Disease
• Knee Infection

Interventions

Type	Name	Description
DRUG	[F-18]MHF	Following intravenous injection of 10 ± 2 mCi (370 ± 74 MBq) \[F-18\]MHF as a bolus, dynamic PET imaging of the lower limbs will be acquired for approximately 90 minutes. The acquired images will be processed. The uptake pattern of \[F-18\]MHF around infected orthopedic knee implant will be determined and compared with its uptake pattern around non-infected knee implants.

Timeline

• Start date: 2024-11-04
• Primary completion: 2026-03-31
• Completion: 2026-03-31
• First posted: 2023-06-05
• Last updated: 2025-07-25

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study