Clinical trial NCT02689401: MRI Iron Oxide Imaging for Lymph Node Staging in Esophageal Cancer
Official title: MRI Iron Oxide Imaging for Lymph Node Staging in Esophageal Cancer
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Esophageal Cancer
Keywords: Esophageal Cancer
lymph nodes tumor
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
Collaborators: name: AMAG Pharmaceuticals, Inc.
First posted: 2016-02-24
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This research study is evaluating a new imaging method using MRI (magnetic resonance imaging) to evaluate lymph nodes for evidence of tumor spread from esophageal cancer. This MRI study involves an intravenous contrast called Ferumoxytol (FerahemeTM).

Detailed description: This research study is a Pilot clinical trial, which is the first time investigators are examining this study intervention.

This study tests the safety of the investigational intervention (MRI imaging with Ferumoxytol) and assesses the feasibility of identifying malignant lymph nodes (lymph nodes that have tumor in them) by comparing the experimental MRI findings with the final pathology report from surgery.

This iron-based agent currently has approval from the U.S. Food and Drug Administration (FDA) for use in iron replacement therapy, however, its use in MRI imaging is not FDA-approved and is thus experimental in this trial.

Eligibility criteria: Inclusion Criteria:

* Participants may have histologically confirmed esophageal cancer or lesion suspicious for esophageal cancer which is deemed surgically resectable.
* Patients eligible for the trial may have previously completed neoadjuvant chemoradiation per standard protocols prior to MRI imaging, without any limitations on dose, duration or type of prior treatment as this is not the focus of the current study.
* Eligible patients must be 18 years or older in order to consent for this trial. Individuals under the age of 18 are excluded because safety studies including dosing or adverse event data in this population are currently not available.
* Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

* Patients with known allergies or hypersensitivity reactions to parenteral iron, parenteral dextran, parenteral iron-dextran, or parenteral iron-polysaccharides
* Individuals who are pregnant or lactating. As part of their routine preoperative testing, all women of child bearing age receive a pregnancy test. The research staff will follow up on these results in order to determine eligibility. Women who have had a hysterectomy or have not had menses for \> 24 months will not be required to undergo a pregnancy test. Pregnant women are excluded from this study because there is unknown risk associated with Ferumoxytol (US FDA Risk Category C: there are no controlled studies in women, or no studies are available in either animals or women). Because there is an unknown but potential risk of adverse events in nursing infants secondary to treatment of the mother, breastfeeding women will be excluded from this study
* Iron saturation above the upper limit of normal
* Individuals with known clinical conditions that may lead to iron overload including hemochromatosis, cirrhosis, or sickle cell disease
* Individuals with a contraindication to MRI, such as the presence of metallic prostheses or implanted metal device (e.g. infusion pump, defibrillator)

Primary outcomes:
measure: Determine the feasibility of using MRI-ferumoxytol for the identification of metastatic lymph nodes in patients with esophageal cancer
timeFrame: 2 years
measure: Assess the safety of intravenous ferumoxytol for the use in esophageal cancer patients
timeFrame: 2 years
Secondary outcomes:
measure: Determine the accuracy of MRI-ferumoxytol for the identification of positive metastatic nodes in patients with esophageal cancer
timeFrame: 2 years
Other outcomes:
Locations:
Study officials:
affiliation: Brigham and Women's Hospital
name: Yolonda Colson, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: