Use of Multiparametric MRI in the Management of Head and Neck Cancer: a Retrospective Analysis

Completed

• Conditions: Head and Neck Cancer; Multiparametric MRI; Cervical Lymph Node
• Interventions: Other: multiparametric MRI

• Registration Number: NCT03991533
• Lead Sponsor: AZ Sint-Jan AV

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2016-11-01
• Primary Completion: 2018-09
• Study Completion: 2018-09
• Study First Submitted: 2019-02-13
• Study First Submitted QC: 2019-06-18
• Study First Posted: 2019-06-19
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-23
• Last Update Posted: 2022-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• patients that received a pretreatment multiparametric MRI according to a standardized protocol between December 2016 and December 2018
• histophatologically proven SCC in the head and neck region
• one or multiple clearly distinguishable cervical lymph node(s), that can be unambiguously correlated with the pathology report

Exclusion Criteria

• patients not fulfilling abovementioned criteria
• patients with thyroid or skin cancer
• considerable artefact on MRI
• previous surgery, irradiation or chemotherapy in the HN region

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
affected	multiparametric MRI	patients with a histologically confirmed head and neck tumour
control	multiparametric MRI	histologically confirmed Whartin tumour or pleomorphic adenoma of the parotid gland, without malignant transformation

Primary Outcome Measures

Name	Time	Method
discriminatory value of MRI D-value	preoperative	differentiation between a metastatic cervical lymph node and a non-tumoural lymph node, as based on the final pathology report as the 'gold standard'
discriminatory value of MRI perfusion curve	preoperative	differentiation between a metastatic cervical lymph node and a non-tumoural lymph node, as based on the final pathology report as the 'gold standard'
discriminatory value of MRI ADC	preoperative	differentiation between a metastatic cervical lymph node and a non-tumoural lymph node, as based on the final pathology report as the 'gold standard'