Nano MRI on 7 Tesla in Rectal and Breast Cancer
Rectal Neoplasms, Breast Neoplasms
About this trial
This is an interventional diagnostic trial for Rectal Neoplasms focused on measuring Ferumoxtran, MRI Scans
Eligibility Criteria
Inclusion Criteria:
General criteria:
- Age > 18 years
Inclusion criteria rectal cancer patients:
- Patients with recently histologically proven rectal cancer, who are planned to undergo a total mesorectal excision without neo-adjuvant radiotherapy.
Inclusion criteria breast cancer patients:
- Patients with recently histologically proven breast cancer (Stage II), who are planned for surgery with sentinel node procedure, but will receive no neo-adjuvant therapy or will undergo an axillary lymph node dissection without prior sentinel node procedure and will receive no neo-adjuvant therapy.
Exclusion Criteria:
General exclusion criteria:
- BMI > 30 kg/m2
- Pregnancy
- Karnofsky score <= 70
Contraindications for 7T MRI:
- Epilepsy
- Inability to provide informed consent
- Metal implants that are not compatible with 7 Tesla MRI
Contraindications to USPIO based contrast agents:
- prior allergic reaction to ferumoxtran-10 or any other iron preparation
- prior allergic reaction contributed to dextran or other polysaccharide, in any preparation
- prior allergic reaction to contrast media of any type
- hereditary hemochromatosis, thalassemia, sickle cell anemia;
Exclusion criteria for rectal cancer:
- Inflammatory diseases of the abdomen (such as Crohn's disease)
- Previous abdominal surgery or radiotherapy
Exclusion criteria for breast cancer:
- Prior radiotherapy or surgery to axillae
Sites / Locations
- Radboud University Medical CentreRecruiting
Arms of the Study
Arm 1
Experimental
Breast and rectal cancer
Subjects will receive intravenous dose of ferumoxtran-10. 24-36 hours later a 7 Tesla MRI scan will be performed, to detect lymph node metastases. In rectal cancer patients the mesorectum will be imaged and for breast cancer patients this will be performed in the ipsilateral axilla. Subjects will also undergo a 3 Tesla MRI scan as a comparison to the 7 Tesla MRI scan.