[124I]FIAU PET-CT Scanning in Patients With Pain in a Prosthetic Knee or Hip Joint

Prosthetic Joint Infections Clinical Trial

— PJI  

Official title:

Sensitivity and Specificity of [124I]FIAU PET-CT Scanning in Patients Presenting With Pain in a Prosthetic Knee or Hip Joint

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01705496
• Other study ID #: BVD002
• Status: Terminated
• Phase: Phase 2
• First received: October 10, 2012
• Last updated: February 8, 2016
• Start date: August 2012
• Est. completion date: November 2013

Study information

• Verified date: February 2016
• Source: BioMed Valley Discoveries, Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 23
• Est. completion date: November 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Males or females age >18 years

2. Ability to provide informed consent

3. A plain anterior-posterior (AP) and frog leg lateral X-ray of the hip or knee within 6 weeks of enrollment

4. Need for operative intervention in the opinion of the surgeon to correct the pain in the prosthetic joint

5. Prosthetic joint implant that has been in site for more than 3 months prior to enrolment

6. Having adequate general health to be expected to tolerate surgery adn to survive for 6 months from the time of informed consent

7. Women must be either postmenopausal or surgically sterile

8. Ability to return for all study assessments

9. Clinically euthyroid, or on stable thyroid replacement therapy

Exclusion Criteria:

1. Subjects who are unable to comply with study requirements

2. Indication, in the opinion of the principal investigator, for urgent surgery that would preclude the time needed for PET-CT scanning

3. 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])

4. Alanine aminotransferase (ALT) >5x the upper limit of normal (ULN) OR aspartate aminotransferase (AST) >5X ULN

5. Creatinine clearance <30 mL/min

6. Body mass that exceeds the rating of the CT table

7. Hypersensitivity to iodine

8. Any condition that would put the subject at reasonable risk in the opinion of the investigator

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Prosthetic Joint Infections

Intervention

Radiation:
• [124I]FIAU
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.

Locations

Country	Name	City	State
United States	Mission Hospital	Asheville	North Carolina
United States	OrthoCarolina Research Institute	Charlotte	North Carolina
United States	University of Arkansas for Medical Sciences	Little Rock	Arkansas
United States	Coastal Clinical Research, Inc.	Mobile	Alabama
United States	Hosptial of the University of Pennsylvania	Philadelphia	Pennsylvania
United States	Clinical Trials of Texas, Incorporated	San Antonio	Texas
United States	Gulfcoast Research Institute, LLC	Sarasota	Florida
United States	Washington University School of Medicine	St. Louis	Missouri
United States	Phoenix Clinical Research, LLC	Tamarac	Florida
United States	Tucson Orthopaedic Institute	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
BioMed Valley Discoveries, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Explore Whether the Adjudication Committee Evaluation of a Subject's Infection Status Correlates With Either of the Two Proposed Published Standards	An independent adjudication committee will assess the totality of clinical information from each subject and assign them a status of infected or uninfected. The subject's infection status will be compared with either of the two proposed published standards to determine whether it corelates with any of the current consensus definitions or diagnostic algorithms.; The trial failed primary outcome, and this secondary outcome was not analyzed.	30 +/- 2 days	No
Other	Estimate the Sensitivity and Specificity of Plain X-ray in Detecting Prosthetic Joint Infection	The adjudication committee evaluation of a subject's infection status will be used as the standard of truth to which X-ray is compared.; The trial failed primary outcome, and this secondary outcome was not analyzed.	15 mins	No
Other	Determine the Sensitivity and Specificity of [124I]FIAU vs. Plain X-ray in Detecting Prosthetic Joint Infection	The adjudication committee evaluation of a subject's infection status will be used as the standard of truth to which [124I]FIAU and X-ray are compared.; The trial failed primary outcome, and this secondary outcome was not analyzed.	30 hours	No
Primary	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.	30 hours	No
Secondary	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.	30 +/- 2 days	Yes
Secondary	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.	30 +/- 2 days	No
Secondary	Understand the Prevalence of Prosthetic Joint Infection	The trial failed primary outcome, and this secondary outcome was not analyzed	30 +/- 2 days	No