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

NCT ID: NCT00920023

Last Updated: 2017-07-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-07-31
• Study Completion Date: 2013-02-28

Brief Summary

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.

Detailed Description

• 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.

Conditions

Pancreatic Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

SPIO MRI

Group Type: EXPERIMENTAL

Superparamagnetic Iron Oxide Magnetic Resonance Imaging

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

Other Intervention Names

SPIO MRI; USPIO; Feruoxytol

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Ralph Weissleder, MD

Professor of Radiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ralph Weissleder, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Massachussetts General Hospital

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

08-085

Identifier Type: -

Identifier Source: org_study_id