NOT_YET_RECRUITING
F18-MHF: Orthopedic Implants-Associated Infection Detection
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.
Conditions:
🦠 Knee Disease 🦠 Knee Infection
🗓️ Study Start (Actual) June 2024
🗓️ Primary Completion (Estimated) June 2025
✅ Study Completion (Estimated) June 2025
👥 Enrollment (Estimated) 30
🔬 Study Type OBSERVATIONAL
📊 Phase N/A
Locations:
📍 Atlanta, Georgia, United States

📋 Eligibility Criteria

Description

  • 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
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: Yes

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 25 May 2023
  • First Submitted that Met QC Criteria 25 May 2023
  • First Posted 5 June 2023

Study Record Updates

  • Last Update Submitted that Met QC Criteria 17 January 2024
  • Last Update Posted 18 January 2024
  • Last Verified January 2024