New PET tracer aims to detect hidden implant infections
NCT ID NCT05889286
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a new radioactive tracer called [F-18]MHF to see if it can detect infections around knee implants using PET scans. Researchers will compare the tracer's uptake in infected versus non-infected implants in 18 adults. The goal is to improve diagnosis and reduce unnecessary surgeries for suspected infections.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Fluorine-18 Maltodextrin ([F-18]MHF)
- What this could lead to
- If successful, this could provide a more accurate way to diagnose infections around implants, helping doctors decide if surgery is needed.
- What could go wrong
- This is a small, early-phase study with only 18 participants. The tracer may not reliably distinguish infected from non-infected implants in larger groups.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
-
18 people
The number who actually took part.
- Started
-
Nov 2024
- Finished
-
Mar 2026
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
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.
- Ages
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18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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. * 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. Exclusion Criteria for symptomatic patient cohort: • 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 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 grade ≥3 renal toxicity, septic shock, or other condition in which the opinion of the PI, PET scanning would constitute significant risk.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Emory University Hospital
Atlanta, Georgia, 30322, United States
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Other studies related to the condition(s) this trial covers.
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