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The purpose of this research study is to see if a specific kind of MRI, called Ultrasmall Superparamagnetic Iron Oxide Magnetic Resonance Imaging (USPIO MRI), which uses an FDA-approved therapeutic agent(Feraheme) to see if it is able to identify small and otherwise undetectable lymph node metastases in people who have pancreatic cancer and are scheduled for surgical resection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SPIO MRI | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Superparamagnetic Iron Oxide Magnetic Resonance Imaging | Drug | Two MRIs will be performed over a two day period. The second scan will be done 48 hours after intravenous infusion of ferumoxytol |
| Measure | Description | Time Frame |
|---|---|---|
| To Determine the Sensitivity High Resolution Magnetic Resonance Imaging With Lymphotrophic Superparamagnetic Nanoparticles to Identify Small and Otherwise Undetectable Lymph Node Metastases. | Using Pathology as the gold standard the excised nodes were correlated and the percentage of positive cases were measured on the post contrast exam. Sensitivity is the percentage of positive cases (i.e., metastases confirmed using pathology) identified as positive. | 3 years |
| To Determine the Specificity of High Resolution Magnetic Resonance Imaging With Lymphotrophic Superparamagnetic Nanoparticles to Identify Small and Otherwise Undetectable Lymph Node Metastases. | Using Pathology as the gold standard the excised nodes were correlated and the percentage of true negative nodes were measured on the post contrast exam. Specificity is the percentage of true negative cases as identified as negative. | 3 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ralph Weissleder, MD, PhD | Massachussetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | SPIO MRI | Superparamagnetic Iron Oxide Magnetic Resonance Imaging: Three MRIs will be performed over a two day period. The second scan will be done 48 hours after intravenous infusion of ferumoxytol |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | SPIO MRI | Superparamagnetic Iron Oxide Magnetic Resonance Imaging: Three MRIs will be performed over a two day period. The second scan will be done 48 hours after intravenous infusion of ferumoxytol |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | To Determine the Sensitivity High Resolution Magnetic Resonance Imaging With Lymphotrophic Superparamagnetic Nanoparticles to Identify Small and Otherwise Undetectable Lymph Node Metastases. | Using Pathology as the gold standard the excised nodes were correlated and the percentage of positive cases were measured on the post contrast exam. Sensitivity is the percentage of positive cases (i.e., metastases confirmed using pathology) identified as positive. | Posted | Number | 95% Confidence Interval | percentage of positive cases | 3 years |
|
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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 | SPIO MRI | Superparamagnetic Iron Oxide Magnetic Resonance Imaging: Three MRIs will be performed over a two day period. The second scan will be done 48 hours after intravenous infusion of ferumoxytol |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ralph Weissleder | Massachusetts General Hospital | 6177268226 | RWEISSLEDER@MGH.HARVARD.EDU |
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
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| ID | Term |
|---|---|
| C097921 | ferumoxtran-10 |
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|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
|
| Units | Counts |
|---|
| Participants |
|
|
| Primary | To Determine the Specificity of High Resolution Magnetic Resonance Imaging With Lymphotrophic Superparamagnetic Nanoparticles to Identify Small and Otherwise Undetectable Lymph Node Metastases. | Using Pathology as the gold standard the excised nodes were correlated and the percentage of true negative nodes were measured on the post contrast exam. Specificity is the percentage of true negative cases as identified as negative. | Posted | Number | 95% Confidence Interval | Percentage of true negative sample | 3 years |
|
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| 0 |
| 15 |
| 0 |
| 15 |
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| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |