The use of nano-MRI to detect lymph node metastasen in patients with head and neck cancer.

Validation of USPIO-enhanced MRI for detection of lymph node metastases in head and neck carcinoma: a pilot study. - Validation of nano-MRI in head and neck carcinoma.

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2018-002168-14-NL

Enrollment

Registered

2018-12-11

Start date

2019-02-12

Completion date

Unknown

Last updated

2019-02-28

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

Conditions

Lymph node metastases in patients with squamous cell head and neck carcinoma.

Interventions

Product Name: Ferumoxtran-10 Product Code: Ferumoxtran-10 Pharmaceutical Form: Infusion INN or Proposed INN: FERUMOXTRAN-10 CAS Number:

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Males and females aged >18 years. - Patients with histopathologically proven cT0-4N0-2M0 squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or unknown primary. - Patients planned for a neck dissection. - Patients providing informed consent 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 25 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 25

Exclusion criteria

Exclusion criteria: - Patients who underwent radio- and/or chemotherapy to the neck before surgery. - Patients who had a previous lymphadenectomy in the head and neck region. - Patients who are pregnant and/or breast-feeding. Patients with contraindications to MRI: - Epilepsy - Metallic implants Patients with contraindications to ferumoxtran-10: - 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

Design outcomes

Primary

Measure	Time frame
Secondary Objective: Not applicable;Primary end point(s): Sensitivity and specificity of nano-MRI MRI in detection of (subclinical) lymph node metastases in head-and-neck carcinoma.;Timepoint(s) of evaluation of this end point: One day after intravenous administration of ferumoxtran-10 using MRI.;Main Objective: To validate nano-MRI with histopathology for the detection of lymph node metastases in head-and-neck squamous cell carcinoma.	—

Measure

Time frame

Secondary Objective: Not applicable;Primary end point(s): Sensitivity and specificity of nano-MRI MRI in detection of (subclinical) lymph node metastases in head-and-neck carcinoma.;Timepoint(s) of evaluation of this end point: One day after intravenous administration of ferumoxtran-10 using MRI.;Main Objective: To validate nano-MRI with histopathology for the detection of lymph node metastases in head-and-neck squamous cell carcinoma.

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Secondary

Measure	Time frame
Secondary end point(s): not applicable;Timepoint(s) of evaluation of this end point: not applicable	—

Countries

Netherlands

Contacts

Public ContactUSPIO-NECK information

Radboudumc

daphne.driessen@radboudumc.nl00310243694194

Outcome results

None listed

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