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Recruiting NCT05889286

F18-MHF: Orthopedic Implants-Associated Infection Detection

Trial Parameters

Condition Knee Disease
Sponsor Emory University
Study Type OBSERVATIONAL
Phase N/A
Enrollment 30
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2024-11-04
Completion 2026-03-31
Interventions
[F-18]MHF

Brief 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.

Eligibility Criteria

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 prost

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