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

• Status: Completed
• Trial end date: 2013-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Massachusetts General Hospital
• Treatments: Dextrans; Ferric Compounds; Iron

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