Detecting infections in orthopedic knee implants using a new imaging agent
Phase II Investigation of [F-18]MHF as a PET Tracer to Detect Orthopedic Implants-associated Infection
This study is testing a new imaging agent to see if it can help find infections in knee implants for people who have had knee surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Emory University Academic / other |
| Locations | 1 site (Atlanta, Georgia) |
| Trial ID | NCT05889286 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the effectiveness of a novel imaging agent, [F-18]MHF, in detecting bacterial infections associated with orthopedic knee implants. Participants will receive an intravenous injection of [F-18]MHF, followed by dynamic PET imaging of the lower limbs for approximately 90 minutes. The study aims to compare the uptake patterns of [F-18]MHF in infected versus non-infected knee implants, potentially leading to improved imaging techniques for identifying infections. This approach may provide a more accurate method for distinguishing between bacterial infections and inflammation in patients with knee prosthetics.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with suspected knee prosthetic infections who are scheduled for surgical intervention.
Not a fit: Patients currently undergoing antimicrobial therapy or with significant comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more accurate detection of infections in knee implants, improving patient outcomes and treatment strategies.
How similar studies have performed: While traditional imaging methods have been used, this approach with [F-18]MHF is novel and has not been extensively tested in similar studies.
Eligibility criteria
Show full inclusion / exclusion 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 prosthesis infection * Recent (within 3 months) or current treatment for infected knee prosthesis * Significant comorbidity such as renal failure, septic shock, uncontrolled diabetes
Where this trial is running
Atlanta, Georgia
- Emory University Hospital — Atlanta, Georgia, United States (Recruiting)
Study contacts
- Principal investigator: David Schuster, MD — Emory University
- Study coordinator: David M Schuster, MD
- Email: dschust@emory.edu
- Phone: 404-712-4859
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.