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

Study Overview

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

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.

Pancreatic Cancer

DRUG: Superparamagnetic Iron Oxide Magnetic Resonance Imaging

08-085

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2009-06-10	Results First Submitted 2017-03-21	Last Update Submitted that met QC Criteria 2017-06-26
First Submitted that Met QC Criteria 2009-06-11	Results First Submitted that Met QC Criteria 2017-06-26	Last Update Posted (ACTUAL) 2017-07-25
First Posted (ACTUAL) 2009-06-12	Results First Posted 2017-07-25	Last Verified 2017-06

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Diagnostic

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: SPIO MRI	DRUG: Superparamagnetic Iron Oxide Magnetic Resonance Imaging Two MRIs will be performed over a two day period. The second scan will be done 48 hours after intravenous infusion of ferumoxytol

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: SPIO MRI

DRUG: Superparamagnetic Iron Oxide Magnetic Resonance Imaging

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

Primary Outcome Measures	Measure Description	Time Frame
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.	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.	3 years

Secondary Outcome Measures	Measure Description	Time Frame

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

PRINCIPAL_INVESTIGATOR: Ralph Weissleder, MD, PhD, Massachussetts General Hospital

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Resources

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Clinical Trial Record