Clinical trial NCT03991533: Use of Multiparametric MRI in the Management of Head and Neck Cancer: a Retrospective Analysis
Official title: Use of Multiparametric Magnetic Resonance Imaging in the Management of Head and Neck Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Head and Neck Cancer
Multiparametric MRI
Cervical Lymph Node
Lead sponsor: AZ Sint-Jan AV
Sponsor class: OTHER
First posted: 2019-06-19
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
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

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.

Eligibility criteria: 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

Primary outcomes:
measure: discriminatory value of MRI perfusion curve
timeFrame: preoperative
measure: discriminatory value of MRI ADC
timeFrame: preoperative
measure: discriminatory value of MRI D-value
timeFrame: preoperative
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: AZ Sint-Lucas Brugge
name: Johan Abeloos, MD
role: PRINCIPAL_INVESTIGATOR
References: