CompletedPhase 1

Biodistribution and Dosimetry Evaluation of [124I]FIAU

United States12 participantsStarted 2010-12

Plain-language summary

This protocol will evaluate the biodistribution and dosimetry of \[124I\]FIAU in both healthy volunteers and patients with prosthetic joint infections. This pilot study will also investigate the safety and tolerability of \[124I\]FIAU.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Males or females age \> 18 years
✓. Informed consent
✓. Subjects with chronic medical conditions such as hypertension and diabetes should be considered stable by the principal investigator
✓. Women should be postmenopausal or surgically sterile
✓. Able to return for all study assessments
✓. Operative intervention planned in the 30 days following study enrollment
✓. Prosthetic joint implant in site for more than 3 months prior to enrollment

Exclusion criteria

✕. Unable to comply with study requirements
✕. Indication in the opinion of the principal investigator for surgery within 48 hours of presentation.
✕. Receipt of any antibiotic therapy in the 2 weeks preceding imaging
✕. Immunosuppression, e.g., human immunodeficiency virus (HIV) infection, s/p organ transplantation, receipt of steroids for \> 10 days at \> 10 mg of prednisone equivalent daily within the 90 days prior to enrollment
✕. Requirement for any medication that predisposes to lactic acidosis (e.g., metformin, iron, isoniazid and salicylates; see Appendix A)
✕. Requirement for any medication that has potential mitochondrial toxicity, e.g., nucleoside analogues (zidovudine, didanosine, stavudine)
✕. History of an inherited mitochondrial disorder (e.g., Leber's hereditary neuropathy, neuropathy, ataxia, retinitis pigmentosa and ptosis \[NARP\], myoneurogenic gastrointestinal encephalopathy \[MNGIE\], myoclonic epilepsy with ragged red fibers \[MERFF\] and mitochondrial myopathy, encephalomyopathy, lactic acidosis and stroke-like syndrome \[MELAS\]
✕. Chronic hepatitis B virus (HBV) or hepatitis C virus (HCV) infection

What they're measuring

Determine the biodistribution and dosimetry evaluation of [124I]FIAU

Timeframe: 72 hrs

Trial details

NCT IDNCT01337466

SponsorBioMed Valley Discoveries, Inc

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2012-12

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