An interventional study of USPIO-enhanced MRI in Head and Neck Squamous Cell Carcinoma, sponsored by Radboud University Medical Center. Status unknown at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-10-26.
Sponsored by Radboud University Medical Center · Not applicable, Interventional, and Diagnostic
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.
6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.
This study's planned enrollment of 25 is below the median of 45 across 5,170 interventional studies indexed under Carcinoma.
Browse Carcinoma studies →Radboud University Medical Center is the lead sponsor of 959 studies on the registry; 134 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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The contrast agent ferumoxtran-10 will be administered intravenously under constant medical supervision 24-36 hours before performing a T2\* weighted MRI scan (prior to surgery).
Diagnostic Test: USPIO-enhanced MRI
The USPIO contrast agent will be administered intravenously to the subjects. An MRI scan of the neck region is performed 24-36 hours later to detect lymph node metastases.
Diagnostic accuracy of USPIO-enhanced MRI for detecting lymph node metastases on a level basis.
The images of the USPIO-enhanced MRI will be read by two radiologists who will score each level as cancer (metastases) positive or negative. These results will be compared with the results of pathology which serve as the gold standard to determine the sensitivity, specificity, positive predictive value and negative predictive value of the USPIO-enhanced MRI for detecting lymph node metastases in head-and-neck cancer patients.
Time frame: The data of each patient will be assessed prior to neck dissection surgery.
Diagnostic accuracy of USPIO-enhanced MRI for detecting lymph node metastases on a nodal basis.
The images of the USPIO-enhanced MRI will be read by two radiologists who will score each node as cancer (metastases) positive or negative. These results will be compared with the results of pathology which serve as the gold standard to determine the sensitivity, specificity, positive predictive value and negative predictive value of the USPIO-enhanced MRI for detecting lymph node metastases in head-and-neck cancer patients.
Time frame: The data of each patient will be assessed prior to neck dissection surgery.
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Radboud University Medical Center