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

NCT02857218 | Withdrawn Early Phase 1 DMC FDA Drug

• 2 other identifiers: IRB00012071NCI-2016-01093
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Stage IIB Esophageal Cancer AJCC v7; Stage III Esophageal Cancer AJCC v7; Stage IIIA Esophageal Cancer AJCC v7; Stage IIIB Esophageal Cancer AJCC v7; Stage IIIC Esophageal Cancer AJCC v7

Outcome Measures

Primary Outcomes (2)

• 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%.

  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.

  Up to 18 weeks

Secondary Outcomes (5)

• Accuracy of USPIO - MRI

  Up to 18 weeks

• Reason for accrual failure

  Up to 18 weeks

• Report location and enhancement patterns on USPIO - MRI

  Up to 18 weeks

• Sensitivity and specificity of MRI imaging for all lymph nodes

  Up to 18 weeks

• Sensitivity and specificity of PET/CT imaging

  Up to 18 weeks

Study Arms (1)

Diagnostic (ferumoxytol, MRI)

EXPERIMENTAL

Patients receive ferumoxytol IV over 15 minutes and then undergo ferumoxytol-enhanced MRI (Magnetic Resonance Imaging) after 24-36 hours and before surgery at week 12.

Drug: Ferumoxytol; Procedure: Magnetic Resonance Imaging

Interventions

Ferumoxytol DRUG

Undergo ferumoxytol-enhanced MRI

Also known as: Feraheme, Ferumoxytol Non-Stoichiometric Magnetite

Diagnostic (ferumoxytol, MRI)

Magnetic Resonance Imaging PROCEDURE

Undergo ferumoxytol-enhanced MRI

Also known as: Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MRI, MRI Scan, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging

Diagnostic (ferumoxytol, MRI)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• OHSU Knight Cancer Institute: lead
• Oregon Health and Science University: collaborator

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

Ferrosoferric Oxide; Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Ferric Compounds; Iron Compounds; Inorganic Chemicals; Ferrous Compounds; Minerals; Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Alexander Guimaraes

  OHSU Knight Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 2, 2016
• First Posted: August 5, 2016
• Study Start: April 27, 2018
• Primary Completion: August 19, 2021
• Study Completion: August 19, 2021
• Last Updated: September 16, 2021

Record last verified: 2021-09