We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00920023
First Posted: June 12, 2009
Last Update Posted: July 25, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Ralph Weissleder, MD, Massachusetts General Hospital
  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: Intervention Model: Single Group Assignment
Masking: None (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:


Further study details as provided by Ralph Weissleder, MD, Massachusetts General Hospital:

Primary Outcome Measures:
  • To Determine the Sensitivity High Resolution Magnetic Resonance Imaging With Lymphotrophic Superparamagnetic Nanoparticles to Identify Small and Otherwise Undetectable Lymph Node Metastases. [ Time Frame: 3 years ]
    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.

  • To Determine the Specificity of High Resolution Magnetic Resonance Imaging With Lymphotrophic Superparamagnetic Nanoparticles to Identify Small and Otherwise Undetectable Lymph Node Metastases. [ Time Frame: 3 years ]
    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.


Enrollment: 35
Study Start Date: July 2008
Study Completion Date: February 2013
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Ralph Weissleder, MD, Professor of Radiology, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00920023     History of Changes
Other Study ID Numbers: 08-085
First Submitted: June 10, 2009
First Posted: June 12, 2009
Results First Submitted: March 21, 2017
Results First Posted: July 25, 2017
Last Update Posted: July 25, 2017
Last Verified: June 2017

Keywords provided by Ralph Weissleder, MD, 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
Ferric Compounds
Dextrans
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Hematinics
Anticoagulants
Plasma Substitutes
Blood Substitutes