Pre-Operative Staging of Pancreatic Cancer Using Superparamagnetic Iron Oxide Magnetic Resonance Imaging (SPIO MRI)

Phase 4CompletedNCT00920023

Massachusetts General Hospital35 enrolled

Overview

The purpose of this research study is to see if a specific kind of MRI, called Ultrasmall Superparamagnetic Iron Oxide Magnetic Resonance Imaging (USPIO MRI), which uses an FDA-approved therapeutic agent(Feraheme) to see if it is able to identify small and otherwise undetectable lymph node metastases in people who have pancreatic cancer and are scheduled for surgical resection.

* On the first day, study participants will undergo 2 MRI examinations. A scan will be done prior to administration of the contrast agent (Feraheme) and then a second scan immediately after administration. On the second day, study participants will be asked to return for a third MRI. * All MRI scans will be done at Massachusetts General Hospital.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Pancreatic Cancer

Interventions

Superparamagnetic Iron Oxide Magnetic Resonance ImagingDRUG

Two MRIs will be performed over a two day period. The second scan will be done 48 hours after intravenous infusion of ferumoxytol

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Locally resectable pancreatic mass present on one or more pre-operative imaging modalities * Must demonstrate no evidence of distant metastases as assessed by chest/abdomen/pelvis CT scan * Deemed eligible for resection with curative intent by a treating surgeon who is listed as an investigator on this study * 18 years of age or older * No uncontrolled serious medical or psychiatric illness * Women of childbearing potential must not be pregnant or lactating Exclusion Criteria: * Known allergy to iron or dextran * Pregnant or lactating * Counter-indication to MRI, such as the presence of metallic prostheses or implanted metal device * Sickle cell disease or hemoglobinopathy

Locations (1)

Massachusetts General Hospital

Boston, Massachusetts, United States

Outcomes

Primary Outcomes

To Determine the Sensitivity High Resolution Magnetic Resonance Imaging With Lymphotrophic Superparamagnetic Nanoparticles to Identify Small and Otherwise Undetectable Lymph Node Metastases.

Using Pathology as the gold standard the excised nodes were correlated and the percentage of positive cases were measured on the post contrast exam. Sensitivity is the percentage of positive cases (i.e., metastases confirmed using pathology) identified as positive.

Time frame: 3 years

To Determine the Specificity of High Resolution Magnetic Resonance Imaging With Lymphotrophic Superparamagnetic Nanoparticles to Identify Small and Otherwise Undetectable Lymph Node Metastases.

Using Pathology as the gold standard the excised nodes were correlated and the percentage of true negative nodes were measured on the post contrast exam. Specificity is the percentage of true negative cases as identified as negative.

Time frame: 3 years

Data from ClinicalTrials.gov

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