|Phase IV||Diagnostic||Closed||18 and over||Other||08-085|
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.
- 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
- 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 Lead Organizations/Sponsors
Massachusetts General Hospital
|Ralph Weissleder, MD, PhD||Principal Investigator|
Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00920023
ClinicalTrials.gov processed this data on October 17, 2013
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