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| ID | Type | Description | Link |
|---|---|---|---|
| 5R01NS034608 | U.S. NIH Grant/Contract | View source |
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Due to staffing shortages and lack of funding during Covid.
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| Name | Class |
|---|---|
| National Institute of Neurological Disorders and Stroke (NINDS) | NIH |
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This exploratory study utilizes ferumoxytol, an iron oxide nanoparticle MR contrast agent for imaging various inflammatory processes in the head and neck region, spine, including the central nervous system. The protocol enrolls subjects with radiological or histological diagnosis of unknown, dural, or parenchymal CNS lesions, multiple sclerosis, TIA or stroke, vasculitis, or other vascular lesions; arterial vasculopathy and venous thrombosis; or enlarged cervical lymph nodes. The main purpose of this study is to better understand the underlying cellular mechanisms, contrast agent extravasation, uptake into macrophages and to assess its value in clinical MR imaging.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Inflammatory lesions | Active Comparator | Subjects with dural, central nervous system (CNS) parenchymal based inflammatory, vascular or demyelinating lesions. |
|
| Vascular lesions | Active Comparator | subjects will include those with vascular CNS lesions such as ischemic stroke, transient ischemic attack (TIA) with suspected carotid embolic origin, or vasculopathy involving the carotids, (including diagnosed carotid stenosis >50%) the aorta, or the arteries of the extremities, or diagnosed thrombosis of the intraabdominal, pelvic or extremity veins. |
|
| Lymph nodes | Active Comparator | Subjects with enlarged cervical lymph nodes in which inflammatory processes (reactive lymph nodes) is part of the differentials. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ferumoxytol | Drug | Ferumoxytol will be injected as i.v. bolus(es) at 3ml/s followed by a saline flush. The maximum total dose over 30 to 60 minutes will be 510mg Fe. Separate boluses will be used for perfusion MR and MRA. Ferumoxytol may be diluted up to 28 fold in normal saline to reduce T2* effects in the MR angiography. Rate of administration can be varied based on the subject's iv site, but will never exceed 510mg Fe /17s (as was done in phaseIII trials) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Lesions | 72 hours | |
| Degree of Contrast Enhancement | Scoring system for parameters: Degree of contrast enhancement (1=none, 2=moderate, 3=good, 4=excellent) | 72 hours |
| Assessment of Border Delineation | The scoring parameters were: (1=none, 2=moderate, 3=good, 4=excellent). | 72hrs |
| Internal Morphology of Lesions | The scoring parameters were: (1=poor, 2=moderate, 3=good). | 72hrs |
| Measure | Description | Time Frame |
|---|---|---|
| Ferumoxytol Particles With Histology and Electron Microscopy in Biopsy Samples | 72 hours | |
| Side Effects/Safety of Ferumoxytol When Given During MRI. | Number of serious adverse events attributable to ferumoxytol. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Edward A Neuwelt, MD | Oregon Health and Science University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oregon Health & Science University | Portland | Oregon | 97239 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Group 1: Inflammatory Lesions | Subjects with dural, central nervous system (CNS) parenchymal based inflammatory, vascular or demyelinating lesions. |
| FG001 | Group 2: Vascular Lesions | Subjects with vascular lesions |
| FG002 | Group 3: Lymph Nodes | Subjects with enlarged cervical lymph nodes in which inflammatory processes (reactive lymph nodes) is part of the differentials. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
The study was terminated early due to Covid and funding shortages. Therefore, subject enrollment was not met, and no subjects were enrolled in group 3.
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| ID | Title | Description |
|---|---|---|
| BG000 | Group 1: Inflammatory Lesions | Subjects with dural, central nervous system (CNS) parenchymal based inflammatory, vascular or demyelinating lesions. |
| BG001 | Group 2: Vascular Lesions |
| 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 | Number of Lesions | Due to the study closing prematurely, the images for the 23 subjects in group 2 were collected but not processed for analysis, and no data were collected in group 3 for this measure. | Posted | Mean | Standard Deviation | Number of lesions | 72 hours |
|
From time of ferumoxytol infusion through 30 days after ferumoxytol infusion.
The SAEs reported here are all AEs of grades 3, and 4. The study was terminated early due to Covid and funding shortages. Therefore, subject enrollment was not met, and no subjects were enrolled in group 3.
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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 | Group 1: Inflammatory Lesions | Subjects with dural, central nervous system (CNS) parenchymal based inflammatory, vascular or demyelinating lesions. Ferumoxytol: Ferumoxytol will be injected as i.v. bolus(es) at 3ml/s followed by a saline flush. The maximum total dose over 30 to 60 minutes will be 510mg Fe. Separate boluses will be used for perfusion MR and MRA. Ferumoxytol may be diluted up to 28 fold in normal saline to reduce T2* effects in the MR angiography. Rate of administration can be varied based on the subject's iv site, but will never exceed 510mg Fe /17s (as was done in phaseIII trials) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ataxia | Nervous system disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Amy Huddleston | Oregon Health and Science University | 503-494-2910 | huddlesa@ohsu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 13, 2023 | Aug 1, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D052203 | Ferrosoferric Oxide |
| ID | Term |
|---|---|
| D005290 | Ferric Compounds |
| D058085 | Iron Compounds |
| D007287 | Inorganic Chemicals |
| D005296 | Ferrous Compounds |
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|
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| 30 days |
| Iron Uptake and Clearance in Abdominal Organs, Such as the Liver, Spleen, Pancreas and Bone Marrow by Applying Usual Abdominal MR Sequences at Multiple Time Points | 6 months |
Subjects will include those with vascular CNS lesions such as ischemic stroke, TIA with suspected carotid embolic origin, or atherosclerotic or inflammatory vasculopathy involving the carotids (including diagnosed carotid stenosis >50%), aorta and the arteries of the extremities or thrombosis of the intraabdominal, pelvic or extremity veins.
| BG002 | Group 3: Lymph Nodes | Subjects with enlarged cervical lymph nodes in which inflammatory processes (reactive lymph nodes) is part of the differentials. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 | Group 3: Lymph Nodes | Subjects with enlarged cervical lymph nodes in which inflammatory processes (reactive lymph nodes) is part of the differentials. |
|
|
| Primary | Degree of Contrast Enhancement | Scoring system for parameters: Degree of contrast enhancement (1=none, 2=moderate, 3=good, 4=excellent) | Due to the study closing prematurely, the images for the 23 subjects in group 2 were collected but not processed for analysis, and no data were collected in group 3 for this measure. | Posted | Mean | Standard Deviation | Score of contrast enhancement | 72 hours |
|
|
|
| Primary | Assessment of Border Delineation | The scoring parameters were: (1=none, 2=moderate, 3=good, 4=excellent). | Due to the study closing prematurely, the images for the 23 subjects in group 2 were collected but not processed for analysis, and no data were collected in group 3 for this measure. | Posted | Mean | Standard Deviation | Score assessment of border delineation | 72hrs |
|
|
|
| Primary | Internal Morphology of Lesions | The scoring parameters were: (1=poor, 2=moderate, 3=good). | Due to the study closing prematurely, the images for the 23 subjects in group 2 were collected but not processed for analysis, and no data were collected in group 3 for this measure. | Posted | Mean | Standard Deviation | Score of internal morphology of lesions | 72hrs | Lesion | Lesion |
|
|
|
| Secondary | Ferumoxytol Particles With Histology and Electron Microscopy in Biopsy Samples | Due to the study closing prematurely, we did not collect these data. | Posted | 72 hours |
|
|
| Secondary | Side Effects/Safety of Ferumoxytol When Given During MRI. | Number of serious adverse events attributable to ferumoxytol. | Of the 230 subjects enrolled in group 1, 12 withdrew or were taken of study prior to receiving ferumoxytol. The 218 subjects remaining were analyzed. Of the 25 subjects enrolled in group 2, 2 withdrew or were taken of study prior to receiving ferumoxyotol. The 23 subjects remaining were analyzed. | Posted | Number | Number of serious AEs attributable to Fe | 30 days |
|
|
|
| Secondary | Iron Uptake and Clearance in Abdominal Organs, Such as the Liver, Spleen, Pancreas and Bone Marrow by Applying Usual Abdominal MR Sequences at Multiple Time Points | Due to the study closing prematurely, we did not enroll any subjects into this subgroup nor gather any data. | Posted | 6 months |
|
|
| 1 |
| 218 |
| 39 |
| 218 |
| 11 |
| 218 |
| EG001 | Group 2: Vascular Lesions | Subjects with vascular lesions Ferumoxytol: Ferumoxytol will be injected as i.v. bolus(es) at 3ml/s followed by a saline flush. The maximum total dose over 30 to 60 minutes will be 510mg Fe. Separate boluses will be used for perfusion MR and MRA. Ferumoxytol may be diluted up to 28 fold in normal saline to reduce T2* effects in the MR angiography. Rate of administration can be varied based on the subject's iv site, but will never exceed 510mg Fe /17s (as was done in phaseIII trials) | 0 | 23 | 2 | 23 | 2 | 23 |
| EG002 | Group 3: Lymph Nodes | Subjects with enlarged cervical lymph nodes in which inflammatory processes (reactive lymph nodes) is part of the differentials. Ferumoxytol: Ferumoxytol will be injected as i.v. bolus(es) at 3ml/s followed by a saline flush. The maximum total dose over 30 to 60 minutes will be 510mg Fe. Separate boluses will be used for perfusion MR and MRA. Ferumoxytol may be diluted up to 28 fold in normal saline to reduce T2* effects in the MR angiography. Rate of administration can be varied based on the subject's iv site, but will never exceed 510mg Fe /17s (as was done in phaseIII trials) | 0 | 0 | 0 | 0 | 0 | 0 |
| Back Pain | General disorders | Non-systematic Assessment |
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| Hemorrhage | Investigations | Non-systematic Assessment | CNS hemorrhage |
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| Colitis | Gastrointestinal disorders | Non-systematic Assessment |
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| Confusion | Nervous system disorders | Non-systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
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| Diplopia | Eye disorders | Non-systematic Assessment |
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| DVT | Vascular disorders | Non-systematic Assessment |
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| Fatigue | General disorders | Non-systematic Assessment |
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| Fever with ANC<1 | Infections and infestations | Non-systematic Assessment |
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| Anemia | Blood and lymphatic system disorders | Non-systematic Assessment |
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| Hypokalemia | Metabolism and nutrition disorders | Non-systematic Assessment |
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| Hyponatremia | Metabolism and nutrition disorders | Non-systematic Assessment |
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| Incontinence | Renal and urinary disorders | Non-systematic Assessment |
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| Infection | Infections and infestations | Non-systematic Assessment |
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| Insomnia | Psychiatric disorders | Non-systematic Assessment |
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| Ischemia | Nervous system disorders | Non-systematic Assessment |
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| Leg amputation | Surgical and medical procedures | Non-systematic Assessment |
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| Lymphopenia | Blood and lymphatic system disorders | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
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| Neuropathy | Nervous system disorders | Non-systematic Assessment |
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| Pulmonary embolus | Vascular disorders | Non-systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Seizure | Nervous system disorders | Non-systematic Assessment |
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| Shortness of breath | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Somnolence | Nervous system disorders | Non-systematic Assessment |
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| Speech impairment | Nervous system disorders | Non-systematic Assessment |
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| Pain at surgical site | General disorders | Non-systematic Assessment |
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| Thrombocytopenia | Blood and lymphatic system disorders | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | Non-systematic Assessment |
|
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| D008903 |
| Minerals |
| Ferumoxytol |
|
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| Ferumoxtyol |
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|
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| Ferumoxytol |
|
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