A Phase 2 interventional study of [124I]FIAU in Diabetic Foot Infection, sponsored by BioMed Valley Discoveries, Inc. Terminated at 3 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-04-08.
Sponsored by BioMed Valley Discoveries, Inc · Phase 2, Interventional, and Diagnostic
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.
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's enrollment of 4 is below the median of 120 across 4,200 interventional studies indexed under Infections.
Browse Infections studies →BioMed Valley Discoveries, Inc is the lead sponsor of 10 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Single intravenous injection of \[124I\]FIAU in patients with diabetic foot infection
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.
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
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
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
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
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
| Milestone | [124I]FIAU |
|---|---|
| Started | 4 |
| Completed | 4 |
| Not completed | 0 |
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.
| participants | [124I]FIAU |
|---|---|
| Patient positive with both PET-CT and bone biopsy | 0 |
| Patient negative with both PET-CT and bone biopsy | 1 |
| Patient positive with PET-CT only | 1 |
| Patient positive with bone biopsy only | 2 |
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.
| participants with adverse events | [124I]FIAU |
|---|---|
| Assess the Safety and Tolerability of [124I]FIAU | 2 |
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 measurements were reported for this outcome.
Additional information on the extent and localization of infection will be compared to MRI.
No measurements were reported for this outcome.
No measurements were reported for this outcome.
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| [124I]FIAU | — | 1/4 (25%) | 2/4 (50%) |
| Event | [124I]FIAU |
|---|---|
| wound dehiscenceInjury, poisoning and procedural complications | 1/4 |
| Event | [124I]FIAU |
|---|---|
| mild gamma-glutamyl transferase (GGT) increasedInvestigations | 1/4 |
| anemiaBlood and lymphatic system disorders | 1/4 |
| nauseaGastrointestinal disorders | 1/4 |
| coughRespiratory, thoracic and mediastinal disorders | 1/4 |
| hypoglycemiaBlood and lymphatic system disorders | 1/4 |
| chronic renal failureRenal and urinary disorders | 1/4 |
| mild blood alkaline phosphatase increasedInvestigations | 1/4 |
| Age, Categorical(Participants) | [124I]FIAU |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 4 |
| >=65 years | 0 |
| Sex: Female, Male(Participants) | [124I]FIAU |
|---|---|
| Female | 1 |
| Male | 3 |
This study is terminated, as verified in Apr 2016. You cannot join it, but the record below documents what was studied.
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BioMed Valley Discoveries, Inc