Biodistribution and Dosimetry Evaluation of [124I]FIAU

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-12-31

Study Completion Date

2013-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Prosthesis Related 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 healthy volunteers or subjects with prosthetic joint infection who will undergo PET-CT scanning

Group Type EXPERIMENTAL

[124I]FIAU

Intervention Type RADIATION

This is a single dose study of 2 mCi \[124I\]FIAU in healthy volunteers or subjects with prosthetic joint infection of the knee or hip who will undergo serial PET-CT scanning.

Interventions

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[124I]FIAU

This is a single dose study of 2 mCi \[124I\]FIAU in healthy volunteers or subjects with prosthetic joint infection of the knee or hip who will undergo serial PET-CT scanning.

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. Informed consent
3. Subjects with chronic medical conditions such as hypertension and diabetes should be considered stable by the principal investigator
4. Women should be postmenopausal or surgically sterile
5. Able to return for all study assessments

1. Operative intervention planned in the 30 days following study enrollment
2. Prosthetic joint implant in site for more than 3 months prior to enrollment

Exclusion Criteria

1. Unable to comply with study requirements
2. Indication in the opinion of the principal investigator for surgery within 48 hours of presentation.
3. Receipt of any antibiotic therapy in the 2 weeks preceding imaging
4. 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
5. Requirement for any medication that predisposes to lactic acidosis (e.g., metformin, iron, isoniazid and salicylates; see Appendix A)
6. Requirement for any medication that has potential mitochondrial toxicity, e.g., nucleoside analogues (zidovudine, didanosine, stavudine)
7. 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 \[MELAS\]
8. Chronic hepatitis B virus (HBV) or hepatitis C virus (HCV) infection
9. Pre-existing myopathy or neuropathy
10. Abnormal liver function tests defined as alanine aminotransferase (ALT) \> the upper limit of normal (ULN), aspartate aminotransferase (AST) \> ULN, gamma glutamyl transferase (GGT) \> ULN
11. Alcohol use \> 3 units per day in men or 2 units per day in women or active intravenous drug use
12. Creatinine clearance \< 30 mL/min
13. Body mass index \> 40
14. Life expectancy \< 6 months
15. Hypersensitivity to iodine

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes