MRI to detect lymph node metastases using iron contrast and high field MRI in rectal and breast cancer

Conditions: ymph node metastases in rectal cancer, breast cancer and cancer in general
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2014-005011-17-NL

Lead Sponsor: Radboudumc

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

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.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30

Exclusion Criteria

General exclusion criteria:
-BMI > 30 kg/m2
-Pregnancy
-Karnofsky score <= 70
-Contraindications for 7T MRI:
oEpilepsy
oInability to provide informed consent
oMetal implants that are not compatible with 7 Tesla MRI
-Contraindications to USPIO based contrast agents:
oprior allergic reaction to ferumoxtran-10 or any other iron preparation
oprior allergic reaction contributed to dextran or other polysaccharide, in any preparation
oprior allergic reaction to contrast media of any type
ohereditary 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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Validate the results of Nano MRI (use of MRI in combination with ferumoxtran) with actual pathology in rectal and breast cancer;Secondary Objective: Not applicable;Primary end point(s): Sensitivity and specificity of 7T MRI scans with Sinerem enhancement for lymph node metastasis detection. We will make a subdivision into small (<5mm) and large nodes(=5mm).;Timepoint(s) of evaluation of this end point: 1 day after administration of ferumoxtran using 7 Tesla MRI

Secondary Outcome Measures