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Clinical Trials/NL-OMON46202
NL-OMON46202
Recruiting
Not Applicable

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

Radboud Universitair Medisch Centrum0 sites25 target enrollmentTBD

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Not specified
Sponsor
Radboud Universitair Medisch Centrum
Enrollment
25
Status
Recruiting
Last Updated
2 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
2 years ago
Study Type
Observational invasive

Investigators

Eligibility 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

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

Outcomes

Primary Outcomes

Not specified

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