Clinical trial NCT01764919: [124I]FIAU PET-CT Scanning in Diagnosing Osteomyelitis in Patients With Diabetic Foot Infection
Official title: Exploration of the Use of [124I]FIAU Positron Emission Tomography-Computed Tomography Scanning in Diagnosing Osteomyelitis in Patients With Diabetic Foot Infection.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Diabetic Foot Infection
Lead sponsor: BioMed Valley Discoveries, Inc
Sponsor class: INDUSTRY
First posted: 2013-01-10
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

1. Male and female patients \>/= 18 years on the day of signing consent.
2. 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.
3. Ability to provide informed consent
4. 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.
5. For females of childbearing potential, a negative urine pregnancy test on the day of dosing.
6. For females of childbearing potential, a willingness to use 2 methods of contraception for 30 days after receiving \[124I\]FIAU.
7. Ability to return for all study assessments.
8. Clinically euthyroid, or on stable thyroid replacement therapy.

Exclusion Criteria:

1. Patients who ar unable to comply with study requirements.
2. 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.
3. 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 \[MELAS\])
4. Alanine aminotransferase (ALT)\>5x Upper Limit of Normal (ULN) OR aspartate aminotransferase (AST) \>5x ULN.
5. Body mass that exceeds the rating of the CT table.
6. Hypersensitivity to iodine.
7. Pregnant or breast-feeding.
8. Any condition that would put the patient at unreasonable risk in the opinion of the Investigator.

Primary outcomes:
measure: Assess the Sensitivity and Specificity of [124I]FIAU PET-CT Scanning in Detecting Osteomyelitis as Determined by Bone Biopsy in Patients With Diabetic Foot Infection.
timeFrame: 30 hours
Secondary outcomes:
measure: Assess the Safety and Tolerability of [124I]FIAU
timeFrame: 30 +/- 2 days
measure: Compare the Sensitivity and Specificity of [124I]FIAU PET-CT Scanning to Gadolinium-enhanced (GE) Magnetic Resonance Imaging (MRI) and Non-GE-MRI Scanning in Detecting Osteomyelitis in Patients With Diabetic Foot Infection
timeFrame: -2 to 72 hours post dose [124I]FIAU
measure: Assess Any Additional Information That [124I]FIAU PET-CT Scanning Provides Compared to MRI
timeFrame: -2 to 72 hours post dose [124I]FIAU
Other outcomes:
measure: Explore the Performance of [124I]FIAU PET-CT Compared to MRI in Detecting Osteomyelitis by Chronic Kidney Disease (CKD) Stage (Stage 1+2, Stage 3, and Stage 4+5).
timeFrame: -2 hours to 72 hours post dose [124I]FIAU
Locations:
city: Tucson
country: United States
facility: The University of Arizona
state: Arizona
city: Little Rock
country: United States
facility: University of Arkansas for Medical Sciences
state: Arkansas
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
References: