Magnetic Resonance Imaging With Iron Oxide Before Surgery in Finding Disease in Patients With Pancreatic Cancer
Basic Trial Information
|Phase IV||Diagnostic||Active||18 and over||08-085|
This phase IV 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.
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
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
Massachusetts General Hospital
Link to the current ClinicalTrials.gov record.
NLM Identifier NCT00920023
Note: Information about participating sites on pharmaceutical industry trials may be incomplete. Please visit the ClinicalTrials.gov record via the link above for more information about participating sites.