Biodistribution and Dosimetry Evaluation of [124I]FIAU
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01337466|
Recruitment Status : Completed
First Posted : April 19, 2011
Last Update Posted : June 27, 2013
|Condition or disease||Intervention/treatment||Phase|
|Prosthesis Related Infections||Radiation: [124I]FIAU||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Biodistribution and Dosimetry of [124i]FIAU in Patients With Prosthetic Joint Infection of The Knee or Hip and Healthy Subjects Using PET-CT Scanning|
|Study Start Date :||December 2010|
|Actual Primary Completion Date :||December 2012|
|Actual Study Completion Date :||March 2013|
single dose study of [124I]FIAU in healthy volunteers or subjects with prosthetic joint infection who will undergo PET-CT scanning
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.
Other Name: Fialuridine
- Determine the biodistribution and dosimetry evaluation of [124I]FIAU [ Time Frame: 72 hrs ]
Subjects will be dosed with [124I]FIAU at Time 0 on Day 0, and a PET-CT scan will be conducted immediately after the injection. Imaging will be repeated at 2 hours, 4 hours, 6 hours, 24 hours, 48 hours, and 72 hours after dosing.
All images generated will be reviewed for biodistribution and dosimetry.
- Evaluate the safety and tolerability of [124I]FIAU [ Time Frame: 28 +/- 2 days ]Safety will be monitored throughout the study for all subjects. Safety will be assessed by monitoring of adverse events and vital signs, clinical laboratory tests including LFTs, lactate, serum chemistry and CBC, physical examination, and 12-lead ECG.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01337466
|United States, Arkansas|
|University of Arkansas for Medical Sciences|
|Little Rock, Arkansas, United States, 72205|
|United States, Maryland|
|Sinai Hospital of Baltimore|
|Baltimore, Maryland, United States, 21215|
|United States, New York|
|North Shore long Island Jewish Medical Center|
|Lake Success, New York, United States, 11042|
|Principal Investigator:||Michael A Mont, MD||Sinai Hospital of Baltimore|