NCT03280277

Ferumoxytol-Enhanced MRI in Imaging Lymph Nodes in Patients With Locally Advanced Rectal Cancer

Novel Imaging of Lymph Nodes in Patients With Rectal Cancer Using Ferumoxytol Enhanced MRI

• Status: Terminated
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 2 (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 rectal cancer that has spread from where it started to nearby tissue or lymph nodes (locally advanced). 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 rectal cancer when given 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 rectal cancer with enlarged or suspicious lateral pelvic lymph nodes before starting neoadjuvant therapy and again before total mesorectal excision. SECONDARY OBJECTIVES: I. To collect detailed information about the location of ultrasmall superparamagnetic iron oxide (USPIO)-MRI detected lymph nodes prior to neoadjuvant therapy and again prior to total mesorectal excision. II. To compare the sensitivity and specificity of ferumoxytol enhanced MR imaging in assessment of pathological lymph nodes with those of non-USPIO-MRI and positron emission tomography-computed tomography (PET-CT). OUTLINE: Patients receive ferumoxytol intravenously (IV) over 15 minutes and then after 24-36 hours undergo ferumoxytol-enhanced MRI before start of neoadjuvant therapy and within 4 weeks before surgery. After completion of study treatment, patients are followed up for 4-6 weeks.

Conditions

• Locally Advanced Rectal Carcinoma
• Stage III Rectal Cancer AJCC v7
• Stage IIIA Rectal Cancer AJCC v7
• Stage IIIB Rectal Cancer AJCC v7
• Stage IIIC Rectal Cancer AJCC v7

Interventions

Type	Name	Description
PROCEDURE	Contrast-enhanced Magnetic Resonance Imaging	Undergo ferumoxytol-enhanced MRI
DRUG	Ferumoxytol	Given IV

Timeline

• Start date: 2018-04-27
• Primary completion: 2021-08-26
• Completion: 2021-08-26
• First posted: 2017-09-12
• Last updated: 2021-09-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study