F18-MHF: Orthopedic Implants-Associated Infection Detection

Emory University

Status: Enrolling

Conditions: Knee Infection; Knee Disease

Treatments: Drug: [F-18]MHF

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT05889286

5R42AI157552-03 (U.S. NIH Grant/Contract)

STUDY00006008

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and 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

Trial design

30 participants in 2 patient groups

Arm A: Symptomatic patient cohort

Description:

Arm A will consist of 20 patients who have suspected prosthetic infection and who are scheduled to undergo surgery debridement/removal.

Treatment:

Drug: [F-18]MHF

Arm B: Asymptomatic patient cohort

Description:

Arm B will consist of 10 asymptomatic normal control patients who have remotely placed total knee prosthesis without clinical or laboratory evidence of infection per inclusion criteria.

Treatment:

Drug: [F-18]MHF