Diabetic Foot Infection
Conditions
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.
Interventions
RADIATION[124I]FIAU
A single intravenous injection of 5 mCi\[124I\]FIAU in patients with diabetic foot infection who will undergo 2 PET-CT scanning.
Sponsors
BioMed Valley Discoveries, Inc
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 30 hours | 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
| Measure | Time frame | Description |
|---|---|---|
| Assess the Safety and Tolerability of [124I]FIAU | 30 +/- 2 days | 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 | -2 to 72 hours post dose [124I]FIAU | 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 | -2 to 72 hours post dose [124I]FIAU | Additional information on the extent and localization of infection will be compared to MRI. |
Other
| 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). | -2 hours to 72 hours post dose [124I]FIAU |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| [124I]FIAU Single intravenous injection of \[124I\]FIAU in patients with diabetic foot infection
\[124I\]FIAU: A single intravenous injection of 5 mCi\[124I\]FIAU in patients with diabetic foot infection who will undergo 2 PET-CT scanning. | 4 |
| Total | 4 |
Baseline characteristics
| Characteristic | [124I]FIAU |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 4 Participants |
| Sex: Female, Male Female | 1 Participants |
| Sex: Female, Male Male | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 2 / 4 |
| serious Total, serious adverse events | 1 / 4 |
Outcome results
Primary
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.
Time frame: 30 hours
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| [124I]FIAU | 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. | Patient positive with both PET-CT and bone biopsy | 0 participants |
| [124I]FIAU | 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. | Patient negative with both PET-CT and bone biopsy | 1 participants |
| [124I]FIAU | 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. | Patient positive with PET-CT only | 1 participants |
| [124I]FIAU | 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. | Patient positive with bone biopsy only | 2 participants |
Secondary
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.
Time frame: -2 to 72 hours post dose [124I]FIAU
Population: No correlation was seen between FIAU uptake and bone biopsy results (the standard of truth). The secondary and exploratory efficacy endpoints were not assessed.
Secondary
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.
Time frame: 30 +/- 2 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| [124I]FIAU | Assess the Safety and Tolerability of [124I]FIAU | 2 participants with adverse events |
Secondary
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.
Time frame: -2 to 72 hours post dose [124I]FIAU
Population: No correlation was seen between FIAU uptake and bone biopsy results (the standard of truth). The secondary and exploratory efficacy endpoints were not assessed.
Other Pre-specified
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
Population: No correlation was seen between FIAU uptake and bone biopsy results (the standard of truth). The secondary and exploratory efficacy endpoints were not assessed.