This pilot clinical trial studies how well ferumoxytol-enhanced magnetic resonance imaging (MRI) works in imaging lymph nodes in patients with rectal cancer that has spread from where it started to nearby tissue or lymph nodes (locally advanced). Ferumoxytol is a form of very small iron particles that are taken up by cells in normal lymph nodes and may work better in imaging patients with rectal cancer when given with MRI.
PRIMARY OBJECTIVE: I. To determine feasibility of administering ferumoxytol and obtaining ferumoxytol enhanced magnetic resonance (MR) images in patients with resectable locally advanced rectal cancer with enlarged or suspicious lateral pelvic lymph nodes before starting neoadjuvant therapy and again before total mesorectal excision. SECONDARY OBJECTIVES: I. To collect detailed information about the location of ultrasmall superparamagnetic iron oxide (USPIO)-MRI detected lymph nodes prior to neoadjuvant therapy and again prior to total mesorectal excision. II. To compare the sensitivity and specificity of ferumoxytol enhanced MR imaging in assessment of pathological lymph nodes with those of non-USPIO-MRI and positron emission tomography-computed tomography (PET-CT). OUTLINE: Patients receive ferumoxytol intravenously (IV) over 15 minutes and then after 24-36 hours undergo ferumoxytol-enhanced MRI before start of neoadjuvant therapy and within 4 weeks before surgery. After completion of study treatment, patients are followed up for 4-6 weeks.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
2
Undergo ferumoxytol-enhanced MRI
Given IV
OHSU Knight Cancer Institute
Portland, Oregon, United States
Practical feasibility
Assessed by successful accrual objectively, as a percentage of all subjects enrolled. Accrual success will be measured in binary fashion; successful accrual is considered a patient that enrolls and completes the entire trial. All other eligible patients will be considered an accrual failure. Practical feasibility will be considered a success if greater than 50%.
Time frame: Up to 6 weeks
Technical feasibility of ultrasmall superparamagnetic iron oxide (USPIO) - magnetic resonance imaging (MRI) of the chest
Assessed by image quality and protocol completion. Will be evaluated in a descriptive manner. Image quality, readability (i.e. the ability for diagnostic radiologist to make an appropriate diagnostic conclusion), completion of ferumoxytol infusion, data acquisition, and completion of magnetic resonance protocol.
Time frame: Up to 6 weeks
Reason for accrual failure
Time frame: Up to 6 weeks
Report location and enhancement patterns on USPIO - MRI
Time frame: Up to 6 weeks
Sensitivity and specificity of MRI imaging for all lymph nodes
Assessed by pathology finding. Sensitivities and specificities of ferumoxytol enhanced MRI prior to neoadjuvant therapy will be calculated using pathology finding as the gold standard. Each lymph node will be treated as an independent observation. The sensitivity and specificity will be compared with those from positron emission tomography (PET)/computed tomography (CT) findings using McNemar's test. Sensitivities and specificities of ferumoxytol enhanced MRI before surgery will also be calculated as a reference.
Time frame: Up to 6 weeks
Sensitivity and specificity of PET/CT imaging
Assessed by pathology finding. Sensitivities and specificities of ferumoxytol enhanced MRI prior to neoadjuvant therapy will be calculated using pathology finding as the gold standard. Each lymph node will be treated as an independent observation. The sensitivity and specificity will be compared with those from PET/CT findings using McNemar's test. Sensitivities and specificities of ferumoxytol enhanced MRI before surgery will also be calculated as a reference.
Time frame: Up to 6 weeks
Accuracy of USPIO - MRI
Accuracy, which is defined as the percentage of all patients or lymph nodes in which MRI with ferumoxytol correctly predicted the presence or absence of metastatic tumor, will be calculated.
Time frame: Up to 6 weeks
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