[124I]FIAU PET-CT Scanning in Diagnosing Osteomyelitis in Patients With Diabetic Foot Infection

Stopped early · Phase 2

Conditions studied: Diabetic Foot Infection

In brief

This protocol will evaluate the sensitivity and specificity of \[124I\]FIAU as a diagnostic imaging agent for the detection of osteomyelitis in patients with diabetic foot infection.

Key facts

Study ID

NCT01764919

Run by

BioMed Valley Discoveries, Inc

People needed

4

Starts

2013-04-01

Expected to finish

2014-02-01

Last updated by the study team

2016-04-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male and female patients >/= 18 years on the day of signing consent.
• A diagnosis of diabetes mellitus, type I or II, as evidenced either by HbA1c>6.5% or receipt of antidiabetic medication at time of enrollment.
• Ability to provide informed consent
• An inframalleolar ulcer of perfusion, extent/size, depth/tissue loss, infection and sensation (PEDIS) grade 2 or 3. At the discretion of the Investigator, patients with PEDIS grade 4 infections may be included if they are sufficiently stable.
• For females of childbearing potential, a negative urine pregnancy test on the day of dosing.
• For females of childbearing potential, a willingness to use 2 methods of contraception for 30 days after receiving [124I]FIAU.
• Ability to return for all study assessments.
• Clinically euthyroid, or on stable thyroid replacement therapy.

You may not qualify if…

• Patients who ar unable to comply with study requirements.
• Indication, in the opinion of the principal Investigator for urgent surgery that would preclude the time needed for PET-CT scanning, or clinical instability that precludes PET-CT scanning.
• History of an inherited mitochondrial disorder (eg. 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])
• Alanine aminotransferase (ALT)>5x Upper Limit of Normal (ULN) OR aspartate aminotransferase (AST) >5x ULN.
• Body mass that exceeds the rating of the CT table.
• Hypersensitivity to iodine.
• Pregnant or breast-feeding.
• Any condition that would put the patient at unreasonable risk in the opinion of the Investigator.

Where it is running

• The University of Arizona — Tucson, Arizona, United States
• University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States
• University of Pennsylvania — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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