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 range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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

View on ClinicalTrials.gov More Prosthesis Related Infections trials