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

USPIO- enhanced High Field MRI for restaging lymph node status in rectal cancer: an explorative study - Nano-MRI in locally advanced rectal cancer

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-002588-32-NL

Enrollment

Registered

2016-08-08

Start date

2016-09-15

Completion date

Unknown

Last updated

2025-01-07

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

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

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: o Planned to undergo neoadjuvant radiotherapy 50.4 Gy with concomitant chemotherapy consisting of capecitabin 825-1000 mg/m2 and/or oxaliplatin 85 mg/m² . and o Planned to undergo a total mesorectal excision. 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 20 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20

Exclusion criteria

Exclusion criteria: General exclusion criteria: - Abdominal circumference > 120cm - Pregnancy - Karnofsky score <= 70 - Contraindications for 3T MRI: o Epilepsy o Inability to provide informed consent o Metal implants that are not compatible with 3 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; - Contraindications to bisacodyl or butylscopolamine: o cardiac arrhythmia, o myasthenia gravis, o urinary retention, o gastrointestinal stenoses, o kidney failure o glaucoma, - Inflammatory diseases of the abdomen (such as Crohn’s disease) - Previous abdominal surgery or radiotherapy

Design outcomes

Secondary

Measure	Time frame
Secondary end point(s): comparison between 3T and 7T on sensitivity and specificity;Timepoint(s) of evaluation of this end point: 1-2 weeks before total mesorectal excision.	—

Primary

Measure	Time frame
Main Objective: Validate the results of Nano MRI (use of MRI in combination with ferumoxtran) with actual pathology in rectal cancer;Secondary Objective: compare 7 tesla and 3 tesla MRI for lymph node detection in locally advanced rectal cancer;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: 1-2 weeks before total mesorectal excision.	—

Measure

Time frame

Main Objective: Validate the results of Nano MRI (use of MRI in combination with ferumoxtran) with actual pathology in rectal cancer;Secondary Objective: compare 7 tesla and 3 tesla MRI for lymph node detection in locally advanced rectal cancer;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: 1-2 weeks before total mesorectal excision.

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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