Pre-Operative Staging of Pancreatic Cancer Using Superparamagnetic Iron Oxide Magnetic Resonance Imaging (SPIO MRI)
This trial is active, not recruiting.
|Treatment||superparamagnetic iron oxide magnetic resonance imaging|
|Sponsor||Massachusetts General Hospital|
|Start date||July 2008|
|End date||October 2013|
|Trial size||100 participants|
|Trial identifier||NCT00920023, 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.
|Endpoint classification||efficacy study|
|Intervention model||single group assignment|
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
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
Male or female participants at least 18 years old.
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
|Official title||Improved Pre-Operative Staging of Pancreatic Cancer Using Superparamagnetic Iron Oxide Magnetic Resonance Imaging (SPIO MRI)|
|Principal investigator||Ralph Weissleder, MD, PhD|
|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.|
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