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Clinical Trials (PDQ®)

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

Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IVDiagnosticClosed18 and overOther08-085
NCT00920023

Trial Description

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.

Further Study Information

  • 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 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

Trial Contact Information

Trial Lead Organizations/Sponsors

Massachusetts General Hospital

Ralph Weissleder, MD, PhDPrincipal Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00920023
ClinicalTrials.gov processed this data on August 01, 2014

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.

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