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No correlation between FIAU uptake and bone biopsy results.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| [124I]FIAU | Experimental | Single intravenous injection of [124I]FIAU in patients with diabetic foot infection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [124I]FIAU | Radiation | A single intravenous injection of 5 mCi[124I]FIAU in patients with diabetic foot infection who will undergo 2 PET-CT scanning. |
|
| 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. | 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. | 30 hours |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 30 +/- 2 days |
| 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 |
| Measure | Description | 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Arizona | Tucson | Arizona | 85724 | United States | ||
| University of Arkansas for Medical Sciences |
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| ID | Title | Description |
|---|---|---|
| FG000 | [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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | [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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Number | participants | 30 hours |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | [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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| wound dehiscence | Injury, poisoning and procedural complications |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| mild gamma-glutamyl transferase (GGT) increased | Investigations |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Michelle Zhang, Executive Director | Biomed valley discoveries | 7815339412 | mzhang@biomed-valley.com |
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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. |
| -2 to 72 hours post dose [124I]FIAU |
| 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. | -2 to 72 hours post dose [124I]FIAU |
| Little Rock |
| Arkansas |
| 72205 |
| United States |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| 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. | Posted | Number | participants with adverse events | 30 +/- 2 days |
|
|
|
| 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. | No correlation was seen between FIAU uptake and bone biopsy results (the standard of truth). The secondary and exploratory efficacy endpoints were not assessed. | Posted | -2 to 72 hours post dose [124I]FIAU |
|
|
| 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. | No correlation was seen between FIAU uptake and bone biopsy results (the standard of truth). The secondary and exploratory efficacy endpoints were not assessed. | Posted | -2 to 72 hours post dose [124I]FIAU |
|
|
| 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). | No correlation was seen between FIAU uptake and bone biopsy results (the standard of truth). The secondary and exploratory efficacy endpoints were not assessed. | Posted | -2 hours to 72 hours post dose [124I]FIAU |
|
|
| 1 |
| 4 |
| 2 |
| 4 |
| anemia | Blood and lymphatic system disorders |
|
| nausea | Gastrointestinal disorders |
|
| cough | Respiratory, thoracic and mediastinal disorders |
|
| hypoglycemia | Blood and lymphatic system disorders |
|
| chronic renal failure | Renal and urinary disorders |
|
| mild blood alkaline phosphatase increased | Investigations |
|
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