Clinical trial · Interventional
MRI Iron Oxide Imaging for Lymph Node Staging in Esophageal Cancer
NCT02689401CI-TRIAL-00022140withdrawnPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Awaiting additional safety data
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Esophageal Cancer | Malignant Esophageal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ferumoxytol | Drug | — | UNRESOLVED |
| MRI 3T scanner | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Ferumoxtyol (Feraheme) with MRI
- 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.
- interventionNames
- Drug: Ferumoxytol
- Device: MRI 3T scanner
Primary outcomes (2)
- measure
- Determine the feasibility of using MRI-ferumoxytol for the identification of metastatic lymph nodes in patients with esophageal cancer
- timeFrame
- 2 years
- 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
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (0)
Data not yet available
No reference posted for this study.