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

Recruiting

Conditions: head and neck cancer
head and neck carcinoma
10027476

Registration Number: NL-OMON46202

Lead Sponsor: Radboud Universitair Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 25

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

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Sensitivity and specificity of the USPIO-enhanced MRI detecting (subclinical)<br /><br>lymph node metastases in head-and-neck cancer. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Development of a scoring system providing criteria for the radiological<br /><br>assessment of USPIO-enhanced MR images regarding the assessment of cervical<br /><br>lymph nodes.</p><br>