- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01764919
[124I]FIAU PET-CT Scanning in Diagnosing Osteomyelitis in Patients With Diabetic Foot Infection
April 6, 2016 updated by: BioMed Valley Discoveries, Inc
Exploration of the Use of [124I]FIAU Positron Emission Tomography-Computed Tomography Scanning in Diagnosing Osteomyelitis in Patients With Diabetic Foot Infection.
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
4
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Arizona
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Tucson, Arizona, United States, 85724
- The University of Arizona
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Arkansas
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Little Rock, Arkansas, United States, 72205
- University of Arkansas for Medical Sciences
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- University of Pennsylvania
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: [124I]FIAU
Single intravenous injection of [124I]FIAU in patients with diabetic foot infection
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A single intravenous injection of 5 mCi[124I]FIAU in patients with diabetic foot infection who will undergo 2 PET-CT scanning.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
Time Frame: 30 hours
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A bone biopsy was obtained through a noninfected area and submitted for histology and microbiologic culture.
Cultures were also to be obtained by biopsy after debridement of the ulcer from a clean base.
Subjects were dosed with [124I]FIAU.
PET-CT scanning were performed.
All PET, PET-CT, and CT images, both attenuation corrected and uncorrected, were to be evaluated centrally and independently.
Results from the bone biopsies were not available to the central reader of the PET-CT images.
The sensitivity and specificity of [124I]FIAU PET-CT scanning in detecting osteomyelitis was determined based on its correlation with bone biopsy, the truth standard.
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30 hours
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Assess the Safety and Tolerability of [124I]FIAU
Time Frame: 30 +/- 2 days
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Safety will be monitored for all subjects for the duration of their study participation.
Safety will be assessed by monitoring of adverse events,vital signs, physical exams, and clinical laboratory tests including CBC and serum chemistry.
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30 +/- 2 days
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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
Time Frame: -2 to 72 hours post dose [124I]FIAU
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All PET-CT images will be evaluated centrally and independently by a single radiologist.
Diagnosis of osteomyelitis based on PET-CT will be compared with MRI which is currently the test of choice to diagnose osteomyelitis in diabetic foot infection.
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-2 to 72 hours post dose [124I]FIAU
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Assess Any Additional Information That [124I]FIAU PET-CT Scanning Provides Compared to MRI
Time Frame: -2 to 72 hours post dose [124I]FIAU
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Additional information on the extent and localization of infection will be compared to MRI.
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-2 to 72 hours post dose [124I]FIAU
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Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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).
Time Frame: -2 hours to 72 hours post dose [124I]FIAU
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-2 hours to 72 hours post dose [124I]FIAU
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2013
Primary Completion (Actual)
July 1, 2013
Study Completion (Actual)
February 1, 2014
Study Registration Dates
First Submitted
January 7, 2013
First Submitted That Met QC Criteria
January 8, 2013
First Posted (Estimate)
January 10, 2013
Study Record Updates
Last Update Posted (Estimate)
April 8, 2016
Last Update Submitted That Met QC Criteria
April 6, 2016
Last Verified
April 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Cardiovascular Diseases
- Vascular Diseases
- Skin Diseases
- Endocrine System Diseases
- Disease Attributes
- Diabetic Angiopathies
- Leg Ulcer
- Skin Ulcer
- Diabetes Complications
- Diabetes Mellitus
- Diabetic Neuropathies
- Musculoskeletal Diseases
- Bone Diseases
- Bone Diseases, Infectious
- Foot Ulcer
- Diabetic Foot
- Infections
- Communicable Diseases
- Focal Infection
- Osteomyelitis
Other Study ID Numbers
- BVD003
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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