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

Nano MRI on 7 Tesla: A technical validation study in rectal and breast cancer

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2014-005011-17-NL
Enrollment
Unknown
Registered
2015-01-07
Start date
2015-02-24
Completion date
Unknown
Last updated
2015-03-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lymph node metastases in rectal cancer, breast cancer and cancer in general

Interventions

Product Name: ferumoxtran-10 Product Code: ferumoxtran-10 Pharmaceutical Form: Infusion INN or Proposed INN: FERUMOXTRAN-10 CAS Number: 189047-99-2 Other descriptive name: FERUMOXTRAN-10 Concentration

Sponsors

Radboudumc
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion 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. 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

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
Secondary end point(s): NA;Timepoint(s) of evaluation of this end point: NA—

Countries

Netherlands

Contacts

Public ContactClinical research centre nijmegen

Radboudumc

crcn@crcn.umc.nl

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026