Back to resultsMRI Iron Oxide Imaging for Lymph Node Staging in Esophageal Cancer
Primary Purpose
Esophageal Cancer
Status
Withdrawn
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Ferumoxytol
MRI 3T scanner
Sponsored by
About this trial
This is an interventional diagnostic trial for Esophageal Cancer focused on measuring Esophageal Cancer, lymph nodes tumor
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)
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Ferumoxtyol (Feraheme) with MRI
Arm Description
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.
Outcomes
Primary Outcome Measures
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
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)
Secondary Outcome Measures
Determine the accuracy of MRI-ferumoxytol for the identification of positive metastatic nodes in patients with esophageal cancer
Accuracy is determined by the positive metastatic nodes identified on MRI as compared to those found on pathologic examination
Full Information
NCT ID
NCT02689401
First Posted
February 4, 2016
Last Updated
May 12, 2016
Sponsor
Dana-Farber Cancer Institute
Collaborators
AMAG Pharmaceuticals, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT02689401
Brief Title
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
2. Study Status
Record Verification Date
May 2016
Overall Recruitment Status
Withdrawn
Why Stopped
Awaiting additional safety data
Study Start Date
May 2016 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
May 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dana-Farber Cancer Institute
Collaborators
AMAG Pharmaceuticals, Inc.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Cancer
Keywords
Esophageal Cancer, lymph nodes tumor
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ferumoxtyol (Feraheme) with MRI
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Ferumoxytol
Other Intervention Name(s)
Feraheme
Intervention Type
Device
Intervention Name(s)
MRI 3T scanner
Primary Outcome Measure Information:
Title
Determine the feasibility of using MRI-ferumoxytol for the identification of metastatic lymph nodes in patients with esophageal cancer
Description
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
Time Frame
2 years
Title
Assess the safety of intravenous ferumoxytol for the use in esophageal cancer patients
Description
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)
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Determine the accuracy of MRI-ferumoxytol for the identification of positive metastatic nodes in patients with esophageal cancer
Description
Accuracy is determined by the positive metastatic nodes identified on MRI as compared to those found on pathologic examination
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yolonda Colson, MD PhD
Organizational Affiliation
Brigham and Women's Hospital
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
MRI Iron Oxide Imaging for Lymph Node Staging in Esophageal Cancer
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