MRI Iron Oxide Imaging for Lymph Node Staging in Esophageal Cancer

NCT02689401 | Withdrawn Phase 1 DMC

• 1 other identifier: 15-419
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Esophageal Cancer

Keywords

Esophageal Cancer; lymph nodes tumor

Outcome Measures

Primary Outcomes (2)

• Determine the feasibility of using MRI-ferumoxytol for the identification of metastatic lymph nodes in patients with esophageal cancer

  Feasibility is determined by the ability of the radiologist to identify esophageal associated lymph nodes and which ones may be metastatic based on the uptake of ferumoxytol. Positive nodes are identified by the radiologist based on altered signal in those with ferumoxytol uptake compared to the signal normal lymph nodes on MRI

  2 years

• Assess the safety of intravenous ferumoxytol for the use in esophageal cancer patients

  Safety is determined by none of the 10 patients developing a grade 3 or 4 reaction as per the Common Toxicity Criteria scale (NCI-CTCAE version 4.0)

  2 years

Secondary Outcomes (1)

• Determine the accuracy of MRI-ferumoxytol for the identification of positive metastatic nodes in patients with esophageal cancer

  2 years

Study Arms (1)

Ferumoxtyol (Feraheme) with MRI

EXPERIMENTAL

Patients will undergo a pre-contrast MRI followed by a pre determined dose of of IV Ferumoxyto. Post-contrast MRI imaging will be performed immediately following Ferumoxytol infusion and 48 hours after Ferumoxytol administration with subsequent image analysis.

Drug: Ferumoxytol; Device: MRI 3T scanner

Interventions

Ferumoxytol DRUG

Also known as: Feraheme

Ferumoxtyol (Feraheme) with MRI

MRI 3T scanner DEVICE

Ferumoxtyol (Feraheme) with MRI

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Dana-Farber Cancer Institute: lead
• AMAG Pharmaceuticals, Inc.: collaborator

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

Ferrosoferric Oxide

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

Study Officials

• Yolonda Colson, MD PhD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Yolonda Colson MD PhD

Study Record Dates

• First Submitted: February 4, 2016
• First Posted: February 24, 2016
• Study Start: May 1, 2016
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: May 13, 2016

Record last verified: 2016-05

Data Sharing

• IPD Sharing: Will not share