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F18-MHF: Orthopedic Implants-Associated Infection Detection

F18-MHF: Orthopedic Implants-Associated Infection Detection

Recruiting
18 years and older
All
Phase N/A

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Overview

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.

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.

Eligibility

Inclusion Criteria for symptomatic patient cohort

  • Patients must be 18 years of age or older, able to provide written informed consent, and ability to lie still for PET scanning.
  • Suspected knee prosthetic infection at least 2 months after original prosthesis placement and who are scheduled to undergo surgery debridement/removal based on the clinical assessment of the referring surgeon.
  • Elevated CRP and ESR

Exclusion Criteria for symptomatic patient cohort:

  • Undergoing current or recent antimicrobial therapy (within 1 month)
  • Significant comorbidity such as renal failure, septic shock, uncontrolled diabetes
  • Other clinically likely site of infection

Inclusion Criteria for asymptomatic cohort:

  • Patients must be 18 years of age or older, able to provide written informed consent and ability to lie still for PET scanning
  • Knee prosthesis in situ without complications for 6 months or longer

Exclusion Criteria for asymptomatic cohort:

  • Clinical or laboratory suspicion of knee prosthesis infection
  • Recent (within 3 months) or current treatment for infected knee prosthesis
  • Significant comorbidity such as renal failure, septic shock, uncontrolled diabetes

Study details
    Knee Disease
    Knee Infection

NCT05889286

Emory University

15 October 2025

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