F18-MHF: Orthopedic Implants-Associated Infection Detection

NCT ID: NCT05889286

Last Updated: 2025-07-25

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-11-04
• Study Completion Date: 2026-03-31

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.

Conditions

Knee Disease; Knee Infection

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

[F-18]MHF

Intervention Type: 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.

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.

[F-18]MHF

Intervention Type: 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.

Interventions

[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.

Intervention Type: DRUG

Other Intervention Names

Fluorine-18 Maltodextrin

Eligibility Criteria

Inclusion Criteria

• 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

• 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

• 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

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role: collaborator

Emory University

OTHER

Sponsor Role: lead

Responsible Party

Mark M Goodman

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

David Schuster, MD

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

Emory University Hospital

Atlanta, Georgia, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

David M Schuster, MD

Role: CONTACT

dschust@emory.edu

404-712-4859

Facility Contacts

David M Schuster, MD

Role: primary

dschust@emory.edu

404-712-4859

Other Identifiers

5R42AI157552-03

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00006008

Identifier Type: -

Identifier Source: org_study_id