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Completed

NCT Number: NCT03991533

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Multiparametric MRI

Other

preoperative multiparametric MRI

Primary outcomes

  1. discriminatory value of MRI perfusion curve

    Time frame: 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'

  2. discriminatory value of MRI ADC

    Time frame: 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'

  3. discriminatory value of MRI D-value

    Time frame: 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'

Sponsors and collaborators

Lead sponsor

AZ Sint-Jan AV

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Jun 19, 2019
Registry last updated
Feb 24, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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