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

Use of Multiparametric Magnetic Resonance Imaging in the Management of Head and Neck Cancer

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 Overview

• Status: Completed
• Conditions: Head and Neck Cancer; Multiparametric MRI; Cervical Lymph Node
• Intervention / Treatment: Other: multiparametric MRI

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 Type: Observational
• Enrollment (Anticipated): 30

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
affected; patients with a histologically confirmed head and neck tumour	Other: multiparametric MRI; preoperative multiparametric MRI
control; histologically confirmed Whartin tumour or pleomorphic adenoma of the parotid gland, without malignant transformation	Other: multiparametric MRI; preoperative multiparametric MRI

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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'	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'	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'	preoperative

Collaborators and Investigators

• Sponsor: AZ Sint-Jan AV
• Investigators: Principal Investigator: Johan Abeloos, MD, AZ Sint-Jan Brugge-Oostende AV

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2016
• Primary Completion (Actual): September 1, 2018
• Study Completion (Actual): September 1, 2018

Study Registration Dates

• First Submitted: February 13, 2019
• First Submitted That Met QC Criteria: June 18, 2019
• First Posted (Actual): June 19, 2019

Study Record Updates

• Last Update Posted (Actual): February 24, 2022
• Last Update Submitted That Met QC Criteria: February 23, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Head and Neck Neoplasms
• Other Study ID Numbers: 2360

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No