F18-MHF: Orthopedic Implants-Associated Infection Detection
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Arm A: Symptomatic patient cohort Arm A will consist of 20 patients who have suspected prosthetic infection and who are scheduled to undergo surgery debridement/removal. |
Drug: [F-18]MHF
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.
Other Names:
|
| Arm B: Asymptomatic patient cohort 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. |
Drug: [F-18]MHF
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.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- 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 [2 weeks (14 days) after 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
Secondary Outcome Measures
- 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. [2 weeks (14 days) after surgery]
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.
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Emory University Hospital | Atlanta | Georgia | United States | 30322 |
Sponsors and Collaborators
- Emory University
- National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
- Principal Investigator: David Schuster, MD, Emory University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- STUDY00006008
- 5R42AI157552-03