F18-MHF: Orthopedic Implants-Associated Infection Detection

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Knee Disease; Knee Infection
• Intervention / Treatment: Drug: [F-18]MHF

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 Type: Observational
• Enrollment (Estimated): 30

Contacts and Locations

• Study Contact: Name: David M Schuster, MD; Phone Number: 404-712-4859; Email: dschust@emory.edu

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University Hospital
      • Contact: David M Schuster, MD; Phone Number: 404-712-4859; Email: dschust@emory.edu
      • Principal Investigator: David M Schuster, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

To accomplish the objectives of this proposed study, 20 patients symptomatic for infection of knee prosthesis and 10 patients asymptomatic for infection of knee of their prosthesis will be accrued, each receiving one injection of [F-18]MHF followed by 90 minutes dynamic PET/CT imaging.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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: Fluorine-18 Maltodextrin
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: Fluorine-18 Maltodextrin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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.	2 weeks (14 days) after surgery

Collaborators and Investigators

• Sponsor: Emory University
• Collaborators: National Institute of Allergy and Infectious Diseases (NIAID)
• Investigators: Principal Investigator: David Schuster, MD, Emory University

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2024
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): June 1, 2025

Study Registration Dates

• First Submitted: May 25, 2023
• First Submitted That Met QC Criteria: May 25, 2023
• First Posted (Actual): June 5, 2023

Study Record Updates

• Last Update Posted (Estimated): January 18, 2024
• Last Update Submitted That Met QC Criteria: January 17, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Implant Infection; Implant; Orthopedic implants
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Infections; Communicable Diseases
• Other Study ID Numbers: STUDY00006008; 5R42AI157552-03 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No