Ferumoxytol-Enhanced MRI in Imaging Lymph Nodes in Patients With Stage IIB-IIIC Esophageal Cancer

This is an interventional diagnostic trial for Stage IIB Esophageal Cancer AJCC v7 Read More

Inclusion Criteria:

• Pathologically confirmed, locally advanced, malignancy of the esophagus; the cancer may involve the stomach up to 5 cm; based on multi-disciplinary tumor board discussion, patients are candidates for tri-modality treatment

• Stage T1-4aN1-2, by the American Joint Committee on Cancer (AJCC) 7th edition, based on the following minimum workup:

  • Computed tomography (CT) chest/abdomen with contrast
  • Positron emission tomography (PET)/CT of the whole-body or skull base to mid-thigh
  • Patients must have regional adenopathy and have undergone endoscopic biopsy with endoscopic ultrasound (EUS)-proven peri-esophageal nodal involvement
• Subjects must have had no prior therapy for cancer of the esophagus
• Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%)
• White blood cell count >= 3.0 K/cu mm
• Absolute neutrophil count >= 1.5 K/cu mm
• Platelets >= 100 K/cu mm
• Hemoglobin >= 8.0 g/dl (The use of transfusion or other invention to achieve Hemoglobin [Hgb] >= 8.0 g/dl is acceptable)
• Total bilirubin =< 1.5 X institutional upper limit of normal
• Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 X institutional upper limit of normal
• Creatinine within normal institutional limits OR creatinine clearance >= 60 mL/min/1.73 m^2 for subjects with creatinine levels above institutional normal
• Serum ferritin < 2.0 X institutional upper limit of normal
• Woman of childbearing potential, a negative serum or urine pregnancy test
• Willingness to use adequate contraception for 12 months after completion of all therapy
• Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

• Subjects with cervical or Siewert 3 esophageal carcinoma, that are recommended by the multi-disciplinary tumor board to have treatment other than tri-modality chemo-radiation therapy (RT) followed by esophagectomy
• Subjects with AJCC 7th edition stage TxN0, T4b, and M1 disease
• Prior systemic chemotherapy for esophageal cancer; prior chemotherapy for another malignancy is allowable as long as it has been > 2 years since completion of therapy for previous malignancy
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to ferumoxytol or other agents used in the study
• Prior chest radiation or radiation for esophageal cancer
• History of other malignancy in the past 2 years except non-melanomatous skin cancer, breast ductal carcinoma in situ (DCIS) and low-risk prostate adenocarcinoma
• Medical contraindications to esophagectomy
• Uncontrolled concurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
• Pregnant women are excluded from this study because chemoradiotherapy has the potential for teratogenic or abortifacient effects; because there is an unknown but potential risk for adverse events in nursing infants secondary to the use of ferumoxytol as a contrast agent in the mother, breastfeeding should be discontinued if the mother receives ferumoxytol while nursing; men who are sexually active and not willing/able to use medically acceptable forms of contraception are also excluded from this study
• Subjects with multiple drug allergies and/or subjects who have had an allergic reaction to any intravenous iron replacement product or a known history of hypersensitivity to ferumoxytol
• Subjects with evidence of iron overload
• Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with ferumoxytol
• Patients with renal insufficiency; glomerular filtration rate (GFR) < 60
• Adult patients who require monitored anesthesia for magnetic resonance imaging (MRI) scanning
• Subjects who have a contraindication for MRI: metal in their bodies (a cardiac pacemaker or other incompatible device), are severely agitated, or have an allergy to gadolinium (Gd) contrast material
• Subjects with known hepatic insufficiency or cirrhosis