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NCT03991533 Clinical Trial

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

Head and Neck Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03991533
Other study ID # 2360
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 1, 2016
Est. completion date September 2018

Study information
Verified date February 2022
Source AZ Sint-Jan AV
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 30
Est. completion date September 2018
Est. primary completion date September 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Other:
• multiparametric MRI
preoperative multiparametric MRI

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
AZ Sint-Jan AV

Outcome
Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
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