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The purpose of this study is to determine the diagnostic accuracy of ferumoxytol-enhanced MRI in detecting lymph nodes that have been invaded by tumor cells in patients with colorectal cancer.
This study will investigate the accuracy of ferumoxytol-enhanced MRI in detecting lymph nodes that have been invaded by tumor cells in patients with colorectal cancer. This study will be performed in addition to any ongoing routine care and will not serve as a substitute for any imaging tests that would be routinely performed prior to surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ferumoxytol-enhanced MRI | Experimental | This is a single-arm study. All enrolled patients will have a ferumoxytol-enhanced MRI scan. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ferumoxytol | Drug | All study patients will receive a dose of ferumoxytol for the MRI. Ferumoxytol will be administered intravenously at a dose of 6 mg/kg, for a maximum dose of 510 mg. |
| Measure | Description | Time Frame |
|---|---|---|
| Prospectively evaluate the diagnostic accuracy of ferumoxytol-enhanced MRI in the setting of colorectal cancer with histopathologic analysis as the gold standard. | 3 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Scott E Potenta, MD, PhD | University of Vermont Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Vermont Medical Center | Burlington | Vermont | 05401 | United States |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D052203 | Ferrosoferric Oxide |
| D009682 | Magnetic Resonance Spectroscopy |
| ID | Term |
|---|---|
| D005290 | Ferric Compounds |
| D058085 | Iron Compounds |
| D007287 | Inorganic Chemicals |
| D005296 | Ferrous Compounds |
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|
| Magnetic Resonance Imaging | Other | All study patients will undergo a ferumoxytol-enhanced MRI in addition to any other ongoing care for colorectal cancer. Histopathologic analysis of lymph nodes will be the gold standard for determining lymph node status. |
|
|
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D008903 |
| Minerals |
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |