Pre-Operative Staging of Pancreatic Cancer Using Superparamagnetic Iron Oxide Magnetic Resonance Imaging (SPIO MRI)

Mass General Brigham

Status and phase

Completed

Phase 4

Conditions

Pancreatic Cancer

Treatments

Drug: Superparamagnetic Iron Oxide Magnetic Resonance Imaging

Study type

Interventional

Funder types

Other

Identifiers

NCT00920023

08-085

Details and patient eligibility

About

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.

Full 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.

Enrollment

35 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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