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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Ralph Weissleder, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00920023
First received: June 10, 2009
Last updated: March 19, 2013
Last verified: March 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Pancreatic Cancer
 Drug: Superparamagnetic Iron Oxide Magnetic Resonance Imaging
 Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Improved Pre-Operative Staging of Pancreatic Cancer Using Superparamagnetic Iron Oxide Magnetic Resonance Imaging (SPIO MRI)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • To determine the sensitivity and specificity of high resolution magnetic resonance imaging with lymphotrophic superparamagnetic nanoparticles to identify small and otherwise undetectable lymph node metastases. [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To compare disease-free survival and overall survival intervals for patients whose pre-operative imaging and surgical resection pathology showed no evidence of nodal metastases. [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: July 2008
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Superparamagnetic Iron Oxide Magnetic Resonance Imaging
    Three MRIs will be performed over a two day period. The second scan will be done 48 hours after intravenous infusion of ferumoxytol
    Other Names:
    • SPIO MRI
    • USPIO
    • Feruoxytol
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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00920023

Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Ralph Weissleder, MD, PhD Massachussetts General Hospital
  More Information

No publications provided

Responsible Party: Ralph Weissleder, MD, Professor of Radiology, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00920023     History of Changes
Other Study ID Numbers: 08-085
Study First Received: June 10, 2009
Last Updated: March 19, 2013
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by Massachusetts General Hospital:
SPIO MRI
Feridex

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
 Endocrine System Diseases
Iron
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 22, 2013