F18-MHF: Orthopedic Implants-Associated Infection Detection

Emory University30 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Knee Disease Knee Infection

Interventions

[F-18]MHFDRUG

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.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Emory University Hospital

Atlanta, Georgia, United States

RECRUITING

Outcomes

Primary Outcomes

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

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

Time frame: 2 weeks (14 days) after surgery

Secondary Outcomes

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.

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.

Time frame: 2 weeks (14 days) after surgery

Central Contacts

David M Schuster, MD

CONTACT

404-712-4859 dschust@emory.edu

Data from ClinicalTrials.gov

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