Back to results[124I]FIAU PET-CT Scanning in Diagnosing Osteomyelitis in Patients With Diabetic Foot Infection
Primary Purpose
Diabetic Foot Infection
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
[124I]FIAU
Sponsored by
About this trial
This is an interventional diagnostic trial for Diabetic Foot Infection
Eligibility Criteria
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.
Sites / Locations
- The University of Arizona
- University of Arkansas for Medical Sciences
- University of Pennsylvania
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
[124I]FIAU
Arm Description
Single intravenous injection of [124I]FIAU in patients with diabetic foot infection
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Assess the Safety and Tolerability of [124I]FIAU
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.
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
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.
Assess Any Additional Information That [124I]FIAU PET-CT Scanning Provides Compared to MRI
Additional information on the extent and localization of infection will be compared to MRI.
Full Information
NCT ID
NCT01764919
First Posted
January 7, 2013
Last Updated
April 6, 2016
Sponsor
BioMed Valley Discoveries, Inc
1. Study Identification
Unique Protocol Identification Number
NCT01764919
Brief Title
[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
2. Study Status
Record Verification Date
April 2016
Overall Recruitment Status
Terminated
Why Stopped
No correlation between FIAU uptake and bone biopsy results.
Study Start Date
April 2013 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
February 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
BioMed Valley Discoveries, Inc
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Foot Infection
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
4 (Actual)
8. Arms, Groups, and Interventions
Arm Title
[124I]FIAU
Arm Type
Experimental
Arm Description
Single intravenous injection of [124I]FIAU in patients with diabetic foot infection
Intervention Type
Radiation
Intervention Name(s)
[124I]FIAU
Intervention Description
A single intravenous injection of 5 mCi[124I]FIAU in patients with diabetic foot infection who will undergo 2 PET-CT scanning.
Primary Outcome Measure Information:
Title
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.
Description
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.
Time Frame
30 hours
Secondary Outcome Measure Information:
Title
Assess the Safety and Tolerability of [124I]FIAU
Description
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.
Time Frame
30 +/- 2 days
Title
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
Description
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.
Time Frame
-2 to 72 hours post dose [124I]FIAU
Title
Assess Any Additional Information That [124I]FIAU PET-CT Scanning Provides Compared to MRI
Description
Additional information on the extent and localization of infection will be compared to MRI.
Time Frame
-2 to 72 hours post dose [124I]FIAU
Other Pre-specified Outcome Measures:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
The University of Arizona
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Facility Name
University of Arkansas for Medical Sciences
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
12. IPD Sharing Statement
Learn more about this trial
[124I]FIAU PET-CT Scanning in Diagnosing Osteomyelitis in Patients With Diabetic Foot Infection
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