F18-MHF: Orthopedic Implants-Associated Infection Detection

Recruiting

• Conditions: Knee Disease; Knee Infection
• Interventions: Drug: [F-18]MHF

• Registration Number: NCT05889286
• Lead Sponsor: Emory University

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.

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 Timeline

• Study First Submitted: 2023-05-25
• Study First Submitted QC: 2023-05-25
• Study First Posted: 2023-06-05
• Study Start: 2024-11-04
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-03
• Last Update Posted: 2024-12-05
• Primary Completion: 2025-06
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Arm B: Asymptomatic patient cohort	[F-18]MHF	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.
Arm A: Symptomatic patient cohort	[F-18]MHF	Arm A will consist of 20 patients who have suspected prosthetic infection and who are scheduled to undergo surgery debridement/removal.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

Emory University Hospital; 🇺🇸 Atlanta, Georgia, United States