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

Sponsor
AZ Sint-Jan AV (Other)
Overall Status
Completed
CT.gov ID
NCT03991533
Collaborator
(none)
30
22

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Anticipated Enrollment :
30 participants
Observational Model:
Case-Control
Time Perspective:
Retrospective
Official Title:
Use of Multiparametric Magnetic Resonance Imaging in the Management of Head and Neck Cancer
Actual Study Start Date :
Nov 1, 2016
Actual Primary Completion Date :
Sep 1, 2018
Actual Study Completion Date :
Sep 1, 2018

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. 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'

  2. 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'

  3. 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'

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • AZ Sint-Jan AV

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Johan Abeloos, Principal investigator, AZ Sint-Jan AV
ClinicalTrials.gov Identifier:
NCT03991533
Other Study ID Numbers:
  • 2360
First Posted:
Jun 19, 2019
Last Update Posted:
Feb 24, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 24, 2022