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

BioMed Valley Discoveries

Status and phase: Terminated; Phase 2

Conditions: Prosthetic Joint Infections

Treatments: Radiation: [124I]FIAU

Study type: Interventional

Funder types: Industry

Identifiers

NCT01705496

BVD002

Details and patient eligibility

About

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.

Enrollment: 23 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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23 participants in 1 patient group

[124I]FIAU

Experimental group

Description:

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

Treatment:

Radiation: [124I]FIAU