An observational study in Head and Neck Cancer, Multiparametric MRI and Cervical Lymph Node, sponsored by AZ Sint-Jan AV. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-02-24.
Sponsored by AZ Sint-Jan AV · Observational
The investigators aim to identify specific MRI parameters that could improve diagnostic accuracy of metastatic cervical lymph nodes in patients with a squamous cell carcinoma in the head and neck region.
Background:The locoregional control rates in patients with advanced head and neck cancer remain suboptimal. Accurate diagnosis of metastatic cervical lymph nodes remains challenging. Technological advances in magnetic resonance imaging (MRI) enable to quantify diffusion and perfusion of the tumour and its surrounding tissues, which could improve diagnostic performance.
Objectives: The investigators aim to identify specific MRI parameters that could improve diagnostic accuracy of metastatic cervical lymph nodes in patients with a squamous cell carcinoma in the head and neck region.
Study design: a retrospective study will be set up to explore the diagnostic performance of the selected MRI parameters to differentiate between tumoural and non-tumoural cervical lymph nodes in patients with a histologically confirmed head and neck tumour ('affected group') or histologically confirmed Whartin tumour or pleomorphic adenoma of the parotid gland, without malignant transformation ('control group').
Patients will be screened for inclusion in the analysis if they had a routine preoperative multiparametric MRI, according to a standardised protocol, between the 1st of December 2016 and the 30th of September 2018. All MR images will be screened by the resident to select those patients with one or multiple clearly distinguishable metastatic cervical lymph node(s), which can be clearly correlated with the final pathology report. Other strict inclusion criteria are described in detail in the protocol.
2,403 studies on the registry are indexed under Head and Neck Neoplasms; 559 are open to participants now.
This study's planned enrollment of 30 is below the median of 100 across 453 observational studies indexed under Head and Neck Neoplasms.
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affected group: Histopathologically proven SCC in the HN region control group: Histopathologically proven Whartin tumour or pleomorphic adenoma of the parotid gland, without malignant transformation in the HN region
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Exclusion Criteria:
patients with a histologically confirmed head and neck tumour
Other: multiparametric MRI
histologically confirmed Whartin tumour or pleomorphic adenoma of the parotid gland, without malignant transformation
Other: multiparametric MRI
preoperative multiparametric MRI
discriminatory value of MRI perfusion curve
differentiation between a metastatic cervical lymph node and a non-tumoural lymph node, as based on the final pathology report as the 'gold standard'
Time frame: preoperative
discriminatory value of MRI ADC
differentiation between a metastatic cervical lymph node and a non-tumoural lymph node, as based on the final pathology report as the 'gold standard'
Time frame: preoperative
discriminatory value of MRI D-value
differentiation between a metastatic cervical lymph node and a non-tumoural lymph node, as based on the final pathology report as the 'gold standard'
Time frame: preoperative
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.
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AZ Sint-Jan AV