F18-MHF: Orthopedic Implants-Associated Infection Detection

Knee Disease Clinical Trial

Official title:

Phase II Investigation of [F-18]MHF as a PET Tracer to Detect Orthopedic Implants-associated Infection

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05889286
• Other study ID #: STUDY00006008
• Secondary ID: 5R42AI157552-03
• Status: Not yet recruiting
• Start date: June 2024
• Est. completion date: June 2025

Study information

• Verified date: January 2024
• Source: Emory University
• Contact: David M Schuster, MD
• Phone: 404-712-4859
• Email: dschust[@]emory.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: June 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Infections
• Knee Disease
• Knee Infection

Intervention

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.

Locations

Country	Name	City	State
United States	Emory University Hospital	Atlanta	Georgia

Sponsors (2)

Lead Sponsor	Collaborator
Emory University	National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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.	2 weeks (14 days) after surgery