Trials / Withdrawn
WithdrawnNCT02857218
Ferumoxytol-Enhanced MRI in Imaging Lymph Nodes in Patients With Stage IIB-IIIC Esophageal Cancer
A Pilot Study Using a Novel Imaging of Lymph Nodes in Patients With Locally Advanced Esophageal Cancer Using Ferumoxytol Enhanced MRI
- Status
- Withdrawn
- Phase
- EARLY_Phase 1
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- OHSU Knight Cancer Institute · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
PRIMARY OBJECTIVE: I. To determine feasibility of administering ferumoxytol and obtaining ferumoxytol enhanced magnetic resonance (MR) images in patients with resectable locally advanced esophageal cancer before starting neoadjuvant chemoradiation therapy and again before esophagectomy. SECONDARY OBJECTIVES: I. To collect detailed information about the location of ultrasmall superparamagnetic iron oxide (USPIO)-MRI detected lymph nodes prior to neoadjuvant chemoradiation therapy and again prior to esophagectomy. II. To determine the sensitivity and specificity of ferumoxytol enhanced MR imaging in the assessment of pathologic lymph node involvement based on pathological findings at the time of esophagectomy. OUTLINE: Patients receive ferumoxytol intravenously (IV) over 15 minutes and then undergo ferumoxytol-enhanced MRI after 24-36 hours and before surgery at week 12. After completion of study treatment, patients are followed up for 4-6 weeks.
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Ferumoxytol | Undergo ferumoxytol-enhanced MRI |
| PROCEDURE | Magnetic Resonance Imaging | Undergo ferumoxytol-enhanced MRI |
Timeline
- Start date
- 2018-04-27
- Primary completion
- 2021-08-19
- Completion
- 2021-08-19
- First posted
- 2016-08-05
- Last updated
- 2021-09-16
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02857218. Inclusion in this directory is not an endorsement.