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
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.
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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