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| ID | Type | Description | Link |
|---|---|---|---|
| 5R42AI157552-03 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Allergy and Infectious Diseases (NIAID) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. Also, those with left-ventricular assist devices (LVADs), cardiac electronic devices such as but not restricted to pacemakers and defibrillators, and vascular grafts with high clinical evidence of infection which will be validated by a composite standard of truth. |
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| Arm B: Asymptomatic patient cohort | Arm B will consist of 10 asymptomatic normal control patients who have remotely placed total knee or hip prosthesis without clinical or laboratory evidence of infection per inclusion criteria. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [F-18]MHF | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 2 weeks (14 days) after surgery |
| Number of patients who are positive on [F-18]MHF who also have left-ventricular assist devices (LVADs), cardiac electronic devices and vascular grafts associated infections as established by the standard of truth during surgery | Number of patients who are positive on [F-18]MHF who also have left-ventricular assist devices (LVADs), cardiac electronic devices such as but not restricted to pacemakers and defibrillators, and vascular grafts with high clinical evidence of infection validated by a composite standard of truth. | 2 weeks (14 days) after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria for symptomatic patient cohort
Exclusion Criteria for symptomatic patient cohort:
• Significant comorbidity such as grade ≥3 renal toxicity, septic shock, other condition in which the opinion of the PI, PET scanning would constitute significant risk
Inclusion Criteria for asymptomatic cohort:
Exclusion Criteria for asymptomatic cohort:
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To accomplish the objectives of this proposed study, 20 patients symptomatic for infection of knee or hip prosthesis or cardiac implantable electronic devices, assist devices, or vascular grafts, and 10 patients asymptomatic for infection of knee or hip of their prosthesis will be accrued, each receiving one injection of [F-18]MHF followed by 90 minutes dynamic PET/CT imaging for outpatients and 40 minutes for inpatients. To account for screen failures, dropouts, and withdrawals, 30 and 15 patients will be enrolled in the symptomatic and asymptomatic cohorts, respectively.
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| Name | Affiliation | Role |
|---|---|---|
| David Schuster, MD | Emory University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emory University Hospital | Atlanta | Georgia | 30322 | United States |
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| 2 weeks (14 days) after surgery |