Clinical use of USPIO contrast media in the assessment of pelvic lymph node metastasis in rectal cancer.

Prior treatment

• Subjects unable to provide written informed consent • Age under 18 • Metastatic disease • T1-disease • Allergy to Ferumoxtran-10 or known hypersensitivity to Ferumoxtran-10 or its components • Known history of drug allergy (including hypersensitivity) to other parenteral iron products • Prior severe allergic reactions, including severe asthma and acute drug-induced severe reactions • Clinically documented or risk of primary or secondary iron overloading (e.g. history of thalassemia, sickle cell anemia, hereditary hemochromatosis, multiple iron transfusions for any reason) • Breastfeeding or pregnant women • Women of childbearing potential who are not willing to use effective contraceptive precautions against pregnancy • Prior abdominopelvic radiation • Prior abdominopelvic malignancies • Patients deemed too frail for surgery • Contraindications for MRI (ferromagnetic metallic implants, claustrophobia, MR-incompatible pacemakers, MR-incompatible prosthetic heart valves, severe obesity etc.)

• Voluntarily given and written informed consent. • Males and females over 18 years of age. • Newly diagnosed rectal cancer patients scheduled for direct surgery or SCRT. • Female subjects must be not of child-bearing potential, defined as postmenopausal for at least 1 year or surgically sterile. • Women of childbearing potential (WOCBP) can be included if they take precautions against pregnancy during the study and for at least 3 months thereafter.