Knee DiseaseNCT05889286
F18-MHF: Implants-Associated Infection Detection
An observational study of Knee Disease and Knee Infection, run by Emory University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Knee Disease, Knee Infection
- What is being tested?
- [F-18]MHF
- Type of treatment
- Injection or infusion
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Nov 2024to 31 Mar 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
- 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
Who cannot join
- 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
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase II Investigation of [F-18]MHF as a PET Tracer to Detect 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.
Read the 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
- Being tested
- [F-18]MHF
- Keywords
- Implant, Orthopedic implants, Implant Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[F-18]MHFDrug
Also called Fluorine-18 Maltodextrin
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: [F-18]MHF |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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.
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.
Measured: 2 weeks (14 days) after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2023
- Study start4 Nov 2024
- Primary completion31 Mar 2026
- Study completion31 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee DiseaseStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mark M Goodman, Emory University
- Investigators
- David Schuster, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05889286
- Sponsor's protocol ID
- STUDY00006008
- Other IDs
- 5R42AI157552-03
- Status last verified
- May 2026
- First submitted
- 25 May 2023
- Last updated
- 28 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Investigation of [F-18]MHF as a PET Tracer to Detect Implants-associated Infection
- ClinicalTrials.gov ID
- NCT05889286
- Acronym / sponsor ID
- STUDY00006008
- Conditions
- Knee Disease, Knee Infection
- Keywords
- Implant, Orthopedic implants, Implant Infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- 4 Nov 2024 (actual)
- Primary completion
- 31 Mar 2026 (actual)
- Study completion
- 31 Mar 2026 (actual)
- First posted
- 5 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A: Symptomatic patient cohort | – | Drug: [F-18]MHFArm 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. |
| Arm B: Asymptomatic patient cohort | – | Drug: [F-18]MHFArm 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| [F-18]MHFAlso: Fluorine-18 MaltodextrinFollowing 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. | Drug | Arm A: Symptomatic patient cohort, Arm B: Asymptomatic patient cohort |
Primary outcome
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
Time frame: 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
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
Time frame: 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 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.
1 secondary outcome
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.
Time frame: 2 weeks (14 days) after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Schuster, MD principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Knee Disease and Knee Infection, run by Emory University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: 2 weeks (14 days) after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2026; AzTrials last refreshed its copy on 29 Oct 2026.