validation of uspio-enhanced mri for detection of lymph node metastases in head and neck carcinoma

Conditions: Head and Neck Squamous Cell Carcinoma

Summary: this study evaluates the diagnostic accuracy of uspio enhanced mri for the detection of lymph node metastases in head-and-neck squamous cell carcinoma (scc) using histopathology as a gold standard.

the presence of lymph node metastases has a large impact on prognosis and treatment in head-and neck cancer patients and necessitates treatment intensification. determining lymph node status, however, is a challenge because up to 20% of patients with a pre-operative clinically negative neck will have occult metastases in the neck dissection specimen. one promising technique is uspio-enhanced mri, an mr-imaging technique in which ultrasmall superparamagnetic iron oxide (uspio) particles are intravenously infused as a contrast agent in patients 24-36 hours before the mri examination and has proven to be of value in detecting lymph node metastases in various types of cancer. the investigators want to validate this technique in a cohort of head and neck cancer patients who undergo neck dissection surgery. histopathology wills serve as the gold standard and the correlation will be made on a (neck)level-to-level and node-to-node basis. since the investigators have no experience in reading uspio-enhanced mr images of the neck with 3-dimensional iron-sensitive mr sequences, this study starts with an explorative part and will be followed by the pilot study. the explorative component aims at obtaining knowledge regarding visual features of (non-)metastatic cervical lymph nodes on uspio-enhanced mr images. the purpose is that the observers work through a learning curve. the information obtained will be used to develop a scoring system for the radiologic assessment of cervical lymph nodes in the subsequent part of our study. if uspio-enhanced mri is successful, this may obviate the need for a sentinel node procedure for example. furthermore, it could guide treatment such as the performance of more selective neck dissections and de-escalation of the radiation dose to healthy tissues in order to decrease morbidity but maintaining high cure rates.

Eligibility criteria:
inclusion criteria: * patients with histopathologically proven ct0-4n0-3m0 scc of the oral cavity, oropharynx, hypopharynx, larynx or unknown primary. * patients planned to undergo a neck dissection. * patient provided written 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 with contraindications to mri (epilepsy; claustrophobia; metallic splinters; pacemaker, pacemaker wires or implanted defibrillator; implanted magnets in jaw; arterial clips (carotid arteries); pregnancy; auditory implant, neurogenic bladder stimulator, insulin pump, neurostimulator, baclofen pump; metallic tissue expander after mastectomy; cochlear implant; metallic braces; other foreign bodies implanted) * patients with contraindications to uspio based contrast agents (prior allergic reaction to ferumoxtran-10 or any other iron preparation; prior allergic reaction attributed to dextran or other polysaccharide, in any preparation; hereditary hemochromatosis, hemosiderosis, chronic hemolytic anaemia (e.g. thalassemia, sickle cell anaemia); pregnancy) * unable to provide informed consent.