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

• Status: Withdrawn
• Trial end date: 2021-08-19
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: OHSU Knight Cancer Institute
• Collaborators: National Cancer Institute (NCI); Oregon Health and Science University
• Treatments: Ferrosoferric Oxide

Criteria

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