Preoperative detection of lymph node metastases in pancreatic and periampullary carcinoma using ultrasmall super paramagnetic iron oxide nanoparticle ferumoxtran-10.

Preoperative detection of lymph node metastases in pancreatic and periampullary carcinoma using ultrasmall super paramagnetic iron oxide nanoparticle ferumoxtran-10. - 3T Nano-MRI: a feasibility study in pancreatic and periampullary carcinoma

Status

Active, not recruiting

Phases

Phase 3

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON47341

Enrollment

Registered

2015-10-06

Start date

2017-05-15

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreas carcinoma and periampullary carcinoma

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Sensitivity and specificity both on a regional level and on a patient level of the 3T MRI scan with USPIO contrast agent for detecting lymph node metastases in pancreatic and periampullary cancer.	—

Secondary

Measure	Time frame
Sensitivity and specificity both on a lesion level and on a patient level of the 3T MRI scan with USPIO contrast agent for detecting liver metastases in pancreatic and periampullary cancer. Delineation of the tumor on USPIO-MRI compared to contrast-enhanced CT. Detection of tumor associated macophages in a pancreatic and periampullary carcinoma.	—

Countries

Netherlands

Outcome results