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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-31

Study Completion Date

2013-11-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Prosthetic Joint Infections

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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[124I]FIAU

Single dose study of \[124I\]FIAU in patients presenting with pain in a prosthetic knee or hip joint who will undergo PET-CT scanning.

Group Type EXPERIMENTAL

[124I]FIAU

Intervention Type RADIATION

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.

Interventions

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[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.

Intervention Type RADIATION

Other Intervention Names

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Fialuridine

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No