This pilot clinical trial studies how well ferumoxytol-enhanced magnetic resonance imaging (MRI) works in imaging lymph nodes in patients with stage IIB-IIIC esophageal cancer. 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 esophageal cancer when paired 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 esophageal cancer before starting neoadjuvant chemoradiation therapy and again before esophagectomy. SECONDARY OBJECTIVES: I. To collect detailed information about the location of ultrasmall superparamagnetic iron oxide (USPIO)-MRI detected lymph nodes prior to neoadjuvant chemoradiation therapy and again prior to esophagectomy. II. To determine the sensitivity and specificity of ferumoxytol enhanced MR imaging in the assessment of pathologic lymph node involvement based on pathological findings at the time of esophagectomy. OUTLINE: Patients receive ferumoxytol intravenously (IV) over 15 minutes and then undergo ferumoxytol-enhanced MRI after 24-36 hours and before surgery at week 12. After completion of study treatment, patients are followed up for 4-6 weeks.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Undergo ferumoxytol-enhanced MRI
Undergo ferumoxytol-enhanced MRI
Practical feasibility
Will be 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 18 weeks
Technical feasibility of ultrasmall superparamagnetic iron oxide (USPIO) - magnetic resonance imaging (MRI) of the chest
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 MR protocol.
Time frame: Up to 18 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 18 weeks
Reason for accrual failure
Descriptive statistical analysis of accrual failure will be conducted, counting the number of subjects who fail to complete the entire trial and the reasons for failure.
Time frame: Up to 18 weeks
Report location and enhancement patterns on USPIO - MRI
Time frame: Up to 18 weeks
Sensitivity and specificity of MRI imaging for all lymph nodes
Sensitivities and specificities of ferumoxytol enhanced MRI prior to neoadjuvant chemoRT 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.
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Time frame: Up to 18 weeks
Sensitivity and specificity of PET/CT imaging
Sensitivities and specificities of ferumoxytol enhanced MRI prior to neoadjuvant chemoRT 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 18 weeks