Magnetic Resonance Imaging With Iron Oxide Before Surgery in Finding Disease in Patients With Pancreatic Cancer

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Basic Trial Information

PhaseTypeAgeTrial IDs
No phase specifiedDiagnostic18 and over08-085
NCI-2012-02941, NCT00920023

Trial Description


This clinical trial studies magnetic resonance imaging with iron oxide in finding disease in patients with pancreatic cancer. Diagnostic procedures, such as magnetic resonance imaging with iron oxide, may help find pancreatic cancer and find out how far the disease has spread.

Further Study Information


I. To determine the sensitivity and specificity of high resolution magnetic resonance imaging (MRI) with lymphotrophic superparamagnetic nanoparticles (LSN) to identify small and otherwise undetectable lymph node metastases in patients who are scheduled for surgical resection of pancreatic carcinoma, and to determine whether LSN MRI will identify histologically positive lymph nodes outside the usual field of surgical resection.


I. 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 with historical control cases not staged using LSN MRI.


Patients undergo superparamagnetic iron oxide magnetic resonance imaging (SPIO MRI) at baseline, receive ferumoxytol intravenously (IV), and then undergo SPIO MRI again immediately and within 24-48 hours. Within 2 weeks, patients undergo surgery.

After completion of study treatment, patients are followed up every 6 months for 3 years.

Eligibility Criteria

Inclusion Criteria:

Subjects must have a locally resectable pancreatic mass present on one or more pre-operative imaging modalities; e.g. computed tomography (CT) scan, endoscopic ultrasound, and/or MRI

Subjects much demonstrate no evidence of distant metastases as assessed by chest/abdomen/pelvis CT scan

Subjects must be deemed eligible for resection with curative intent by a treating surgeon who is listed as an Investigator in this study

Subjects must be willing and able to understand and sign informed consent

No uncontrolled serious medical or psychiatric illness

Women of childbearing potential must not be pregnant or lactating

Exclusion Criteria:

Subjects who have a known allergy to iron

Subjects who are pregnant or lactating

Subjects with a counter-indication to MRI, such as the presence of metallic prostheses or implanted metal device (e.g., infusion pump, defibrillator)

Subjects with sickle cell disease or hemoglobinopathy, or other clinical conditions that may lead to iron overload

Trial Contact Information

Trial Lead Organizations / Sponsors / Collaborators

Dana-Farber Harvard Cancer Center

  • National Cancer Institute
Ralph Weissleder, Principal Investigator

Trial Sites



Massachusetts General Hospital

Ralph Weissleder
Ph: 877-726-5130

Ralph Weissleder
Principal Investigator

Link to the current record.
NLM Identifer NCT00920023

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