Nano MRI on 7 Tesla in Rectal and Breast Cancer

• Status: Unknown status
• Trial end date: 2019-11-01
• Target enrollment: 0
• Participant gender: All

Summary

This study evaluates the diagnostic accuracy of an USPIO contrast agent (ferumoxtran-10) in combination with 7 Tesla MRI to detect lymph node metastases in rectal and breast cancer.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Radboud University

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