RecruitingNCT05889286

F18-MHF: Orthopedic Implants-Associated Infection Detection

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


Sponsor

Emory University

Enrollment

30 participants

Start Date

Nov 4, 2024

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria5

  • 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
  • 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 Criteria6

  • 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
  • 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

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Interventions

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.


Locations(1)

Emory University Hospital

Atlanta, Georgia, United States

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NCT05889286


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