Clinical trial NCT05889286: F18-MHF: Orthopedic Implants-Associated Infection Detection
Official title: Phase II Investigation of [F-18]MHF as a PET Tracer to Detect Orthopedic Implants-associated Infection
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Knee Disease
Knee Infection
Keywords: Implant
Orthopedic implants
Implant Infection
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: National Institute of Allergy and Infectious Diseases (NIAID)
First posted: 2023-06-05
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: To accomplish the objectives of this proposed study, 20 patients symptomatic for infection of knee prosthesis and 10 patients asymptomatic for infection of knee of their prosthesis will be accrued, each receiving one injection of \[F-18\]MHF followed by 90 minutes dynamic PET/CT imaging.

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.

Detailed 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 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

Primary outcomes:
measure: Number of patients who are positive on [F-18]MHF who also have orthopedic implant-associated infections as established by the standard of truth during surgery
timeFrame: 2 weeks (14 days) after surgery
Secondary outcomes:
measure: Number of patients who are negative on [F-18]MHF who do not have have orthopedic implant-associated infections as established by the standard of truth during surgery or on clinical examination if surgery not performed.
timeFrame: 2 weeks (14 days) after surgery
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
Study officials:
affiliation: Emory University
name: David Schuster, MD
role: PRINCIPAL_INVESTIGATOR
References: