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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| USPIO enhanced-MRI | Experimental | 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| USPIO-enhanced MRI | Diagnostic Test | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | The data of each patient will be assessed prior to neck dissection surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Daphne Driessen, MD | Contact | +31950008371 | daphne.driessen@radboudumc.nl | |
| Tim Dijkema, MD, PhD | Contact | +31243614515 |
| Name | Affiliation | Role |
|---|---|---|
| Tim Dijkema, MD, PhD | Radboud University Medical Center | Principal Investigator |
| Hans Kaanders, Prof, MD | Radboud University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Radboudumc | Recruiting | Nijmegen | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35776432 | Derived | Driessen DAJJ, Zamecnik P, Dijkema T, Pegge SAH, van Engen-van Grunsven ACH, Takes RP, Kaanders JHAM, Scheenen TWJ. High-Accuracy Nodal Staging of Head and Neck Cancer With USPIO-Enhanced MRI: A New Reading Algorithm Based on Node-to-Node Matched Histopathology. Invest Radiol. 2022 Dec 1;57(12):810-818. doi: 10.1097/RLI.0000000000000902. Epub 2022 Jul 1. |
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| ID | Term |
|---|---|
| D000077195 | Squamous Cell Carcinoma of Head and Neck |
| ID | Term |
|---|---|
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| The data of each patient will be assessed prior to neck dissection surgery. |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |