F18-MHF: Implants-Associated Infection Detection

NCT05889286 | Completed FDA Drug

• 2 other identifiers: STUDY000060085R42AI157552-03
• Study Type: observational
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Disease; Knee Infection

Keywords

Implant; Orthopedic implants; Implant Infection

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (1)

• 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

Study Arms (2)

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.

Drug: [F-18]MHF

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.

Drug: [F-18]MHF

Interventions

[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.

Also known as: Fluorine-18 Maltodextrin

Arm A: Symptomatic patient cohort; Arm B: Asymptomatic patient cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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.
• OR Inpatients or outpatients with standard clinical evidence of infected left-ventricular assist devices (LVADs), cardiac implantable electronic devices (CIEDs) such as but not restricted to pacemakers and defibrillators, and vascular grafts. Patients may be culture positive or negative, have visual evidence of infection such as frank pus, or classic radiographic evidence of infection on cross sectional imaging and/or FDG PET.
• Willingness to abstain from sexual activity involving the exchange of body fluid for 24 hours after the administration of \[F-18\]MHF
• Elevated CRP and ESR for orthopedic devices.

You may not qualify if:

• 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
• 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
• Clinical or laboratory suspicion of knee prosthesis infection
• Recent (within 3 months) or current treatment for infected knee prosthesis
• Significant comorbidity such as grade ≥3 renal toxicity, septic shock, or other condition in which the opinion of the PI, PET scanning would constitute significant risk.

Sponsors & Collaborators

• Emory University: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (1)

Emory University Hospital

Atlanta, Georgia, 30322, United States

Location

Study Officials

• David Schuster, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 25, 2023
• First Posted: June 5, 2023
• Study Start: November 4, 2024
• Primary Completion: March 31, 2026
• Study Completion: March 31, 2026
• Last Updated: May 28, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)