Preoperative detection of lymph node metastases in pancreatic and periampullary carcinoma using ultrasmall super paramagnetic iron oxide nanoparticle ferumoxtran-10.
Phase 3
Completed
- Conditions
- Pancreas carcinoma and periampullary carcinoma10015674
- Registration Number
- NL-OMON47341
- Lead Sponsor
- Radiologie en nucleaire geneeskunde
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 30
Inclusion Criteria
o Age > 18 years
o High index of suspicion of locally resectable or borderline resectable pancreatic or periampullary cancer
o The patient must be operable
Exclusion Criteria
Pregnancy
Previous pancreatic surgery
Inability to provide informed consent
Contraindications for MRI
Contraindications to USPIO based contrast agents
Prior allergic reaction to contrast media of any type
Contraindications for Butylscopolamine
Contraindications for Glucagon
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Sensitivity and specificity both on a regional level and on a patient level of<br /><br>the 3T MRI scan with USPIO contrast agent for detecting lymph node metastases<br /><br>in pancreatic and periampullary cancer. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Sensitivity and specificity both on a lesion level and on a patient level of<br /><br>the 3T MRI scan with USPIO contrast agent for detecting liver metastases in<br /><br>pancreatic and periampullary cancer.<br /><br>Delineation of the tumor on USPIO-MRI compared to contrast-enhanced CT.<br /><br>Detection of tumor associated macophages in a pancreatic and periampullary<br /><br>carcinoma.</p><br>