Prosthetic Joint InfectionsPhase 2PJINCT01705496
[124I]FIAU PET-CT Scanning in Patients With Pain in a Prosthetic Knee or Hip Joint
A Phase 2 study testing [124I]FIAU in people with Prosthetic Joint Infections, run by BioMed Valley Discoveries, Inc at 10 sites in United States.
Trial summary
This protocol will evaluate the sensitivity and specificity of [124I]FIAU as a diagnostic imaging agent for the detection of prosthetic joint infections in patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prosthetic Joint Infections
- What is being tested?
- [124I]FIAU
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 10 sitesUnited States
- Study dates
- Aug 2012to Nov 2013
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Who may be able to join
- Males or females age >18 years
- Ability to provide informed consent
- A plain anterior-posterior (AP) and frog leg lateral X-ray of the hip or knee within 6 weeks of enrollment
- Need for operative intervention in the opinion of the surgeon to correct the pain in the prosthetic joint
- Prosthetic joint implant that has been in site for more than 3 months prior to enrolment
- Having adequate general health to be expected to tolerate surgery adn to survive for 6 months from the time of informed consent
Show all 9Show fewer
- Women must be either postmenopausal or surgically sterile
- Ability to return for all study assessments
- Clinically euthyroid, or on stable thyroid replacement therapy
Who cannot join
- Subjects who are unable to comply with study requirements
- Indication, in the opinion of the principal investigator, for urgent surgery that would preclude the time needed for PET-CT scanning
- History of an inherited mitochondrial disorder (e.g., Leber's hereditary neuropathy; neuropathy; ataxia, retinitis pigmentosa and ptosis [NARP]; myoneurogenic gastrointestinal encephalopathy [MNGIE]; myocolonic epilepsy with ragged red fibers [MERFF]; and mitochondrial myopathy, encephalomyopathy, lactic acidosis and stroke-like syndrome [MELAS])
- Alanine aminotransferase (ALT) >5x the upper limit of normal (ULN) OR aspartate aminotransferase (AST) >5X ULN
- Creatinine clearance <30 mL/min
- Body mass that exceeds the rating of the CT table
- Hypersensitivity to iodine
- Any condition that would put the subject at reasonable risk in the opinion of the investigator
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Mission Hospital
Asheville, North Carolina, 28801
OrthoCarolina Research Institute
Charlotte, North Carolina, 28207
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
Coastal Clinical Research, Inc.
Mobile, Alabama, 36608
Hosptial of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Clinical Trials of Texas, Incorporated
San Antonio, Texas, 78229
Gulfcoast Research Institute, LLC
Sarasota, Florida, 34232
Washington University School of Medicine
St Louis, Missouri, 63110
Phoenix Clinical Research, LLC
Tamarac, Florida, 33321
Tucson Orthopaedic Institute
Tucson, Arizona, 85712
About this study
Official title: Sensitivity and Specificity of [124I]FIAU PET-CT Scanning in Patients Presenting With Pain in a Prosthetic Knee or Hip Joint
This protocol will evaluate the sensitivity and specificity of [124I]FIAU as a diagnostic imaging agent for the detection of prosthetic joint infections in patients.
- Conditions
- Prosthetic Joint Infections
- Being tested
- [124I]FIAU
- Keywords
- Phase II, FIAU, Fialuridine, Prosthetic, Joint, Infection, PET-CT
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[124I]FIAURadiation
Also called Fialuridine
This is a single dose study of 5 mCi [124I]FIAU in subjects presenting with pain in a prosthetic knee or hip joint. Subject will receive two PET-CT scans after [124I]FIAU injection.
| Study group | Role | What they receive |
|---|---|---|
| [124I]FIAU | Experimental | Single dose study of [124I]FIAU in patients presenting with pain in a prosthetic knee or hip joint who will undergo PET-CT scanning. Receives: Radiation: [124I]FIAU |
What is being measured
The primary outcome is the main question the study is designed to answer.
Estimate the Sensitivity and Specificity of [124I]FIAU
The sensitivity and specificity of [124I]FIAU in the detection of prosthetic joint infection was determined based on the correlation of the patient's infection status determined by an independent image reviewer and the infection status assessed by an adjudication committee.
- Presence or absence of infection: Images were to be assessed and optimized on an ongoing basis. The single blinded reader was to assess independently the PET-CT images (attenuation corrected [AC] and non-AC PET plus the AC CT) and provide a diagnosis (infected or uninfected) using the chosen parameter(s) without knowing the results of the surgery. The radiology reviewer was not given any additional clinical information on the patient for reassessments relative to the initial reads. A separate central radiologist was to read the comparator X-rays independently for the presence or absence of infection. All pathology slides were to be read by a single pathologist. Local microbiology results were to be used.
Measured: 30 hours
Secondary outcomes (3)
Evaluate the Safety and Tolerability of [124I]FIAU
Safety will be monitored throughout the study for all subjects. safety will be assessed by monitoring of adverse events,vital signs,physical exams, and clinical laboratory tests including CBC, serum chemistry.
Measured: 30 +/- 2 days
Define PET-CT Interpretation Criteria That Best Differentiate Infected vs Non-infected Prosthetic Joints
The efficacy of [124I]FIAU could not be established due to the non-specific nature of the PET-CT signals caused by the metal artifacts from the prosthesis and pronounced muscle uptake of FIAU. It was impossible to define image review parameters for diagnosis of prosthetic joint infection.
Measured: 30 +/- 2 days
Understand the Prevalence of Prosthetic Joint Infection
The trial failed primary outcome, and this secondary outcome was not analyzed
Measured: 30 +/- 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2012 (estimated)
- Study startAug 2012
- Primary completionMay 2013
- Study completionNov 2013
Why it stopped: The sensitivity and specificity were not able to be assessed in this study due to the poor image quality.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Prosthetic Joint InfectionsStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- BioMed Valley Discoveries, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01705496
- Sponsor's protocol ID
- BVD002
- Acronym
- PJI
- Status last verified
- Feb 2016
- First submitted
- 10 Oct 2012
- Last updated
- 7 Mar 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sensitivity and Specificity of [124I]FIAU PET-CT Scanning in Patients Presenting With Pain in a Prosthetic Knee or Hip Joint
- ClinicalTrials.gov ID
- NCT01705496
- Acronym / sponsor ID
- PJI / BVD002
- Conditions
- Prosthetic Joint Infections
- Keywords
- Phase II, FIAU, Fialuridine, Prosthetic, Joint, Infection, PET-CT
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The sensitivity and specificity were not able to be assessed in this study due to the poor image quality.
- Enrolment
- 23 participants (actual)
- Lead sponsor
- BioMed Valley Discoveries, IncIndustry (pharma, biotech, devices)
- Study start
- Aug 2012
- Primary completion
- May 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 12 Oct 2012 (estimated)
- Results
- Posted 7 Mar 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This protocol will evaluate the sensitivity and specificity of [124I]FIAU as a diagnostic imaging agent for the detection of prosthetic joint infections in patients.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| [124I]FIAU | Experimental | Radiation: [124I]FIAUSingle dose study of [124I]FIAU in patients presenting with pain in a prosthetic knee or hip joint who will undergo PET-CT scanning. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Males or females age >18 years
- Ability to provide informed consent
- A plain anterior-posterior (AP) and frog leg lateral X-ray of the hip or knee within 6 weeks of enrollment
- Need for operative intervention in the opinion of the surgeon to correct the pain in the prosthetic joint
- Prosthetic joint implant that has been in site for more than 3 months prior to enrolment
Key exclusion criteria (8 listed)
- Subjects who are unable to comply with study requirements
- Indication, in the opinion of the principal investigator, for urgent surgery that would preclude the time needed for PET-CT scanning
- History of an inherited mitochondrial disorder (e.g., Leber's hereditary neuropathy; neuropathy; ataxia, retinitis pigmentosa and ptosis [NARP]; myoneurogenic gastrointestinal encephalopathy [MNGIE]; myocolonic epilepsy with ragged red fibers [MERFF]; and mitochondrial myopathy, encephalomyopathy, lactic acidosis and stroke-like syndrome [MELAS])
- Alanine aminotransferase (ALT) >5x the upper limit of normal (ULN) OR aspartate aminotransferase (AST) >5X ULN
- Creatinine clearance <30 mL/min
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 |
|---|---|---|
| [124I]FIAUAlso: FialuridineThis is a single dose study of 5 mCi [124I]FIAU in subjects presenting with pain in a prosthetic knee or hip joint. Subject will receive two PET-CT scans after [124I]FIAU injection. | Radiation | [124I]FIAU |
Primary outcome
Estimate the Sensitivity and Specificity of [124I]FIAU
Time frame: 30 hours
The sensitivity and specificity of [124I]FIAU in the detection of prosthetic joint infection was determined based on the correlation of the patient's infection status determined by an independent image reviewer and the infection status assessed by an adjudication committee. * Presence or absence of infection: Images were to be assessed and optimized on an ongoing basis. The single blinded reader was to assess independently the PET-CT images (attenuation corrected [AC] and non-AC PET plus the AC CT) and provide a diagnosis (infected or uninfected) using the chosen parameter(s) without knowing the results of the surgery. The radiology reviewer was not given any additional clinical information on the patient for reassessments relative to the initial reads. A separate central radiologist was to read the comparator X-rays independently for the presence or absence of infection. All pathology slides were to be read by a single pathologist. Local microbiology results were to be used.
3 secondary outcomes
Evaluate the Safety and Tolerability of [124I]FIAU
Time frame: 30 +/- 2 days
Define PET-CT Interpretation Criteria That Best Differentiate Infected vs Non-infected Prosthetic Joints
Time frame: 30 +/- 2 days
Understand the Prevalence of Prosthetic Joint Infection
Time frame: 30 +/- 2 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing [124I]FIAU in people with Prosthetic Joint Infections, run by BioMed Valley Discoveries, Inc at 10 sites 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 9 inclusion and 8 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: stopped early, as of the sponsor's last update on 7 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Mar 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Estimate the Sensitivity and Specificity of [124I]FIAU (time frame: 30 hours). 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 7 Mar 2016.