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

  • STATUS
    Recruiting
  • End date
    Dec 2, 2028
  • participants needed
    50
  • sponsor
    AZ Sint-Jan AV
Updated on 2 February 2021
ct scan
carcinoma
squamous cell carcinoma
positron emission tomography
advanced head and neck carcinoma

Summary

The investigators aim to validate 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. Moreover, we aim to explore specific MRI parameters that could improve diagnostic accuracy of bone invasion and tumour relapse, as well as predict treatment response and survival in this target population.

Description

Background: The locoregional control rates in patients with advanced head and neck cancer remain suboptimal. Accurate diagnosis of metastatic cervical lymph nodes, bone invasion, or tumour relapse in a previously irradiated or operated field 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. Moreover, they could provide additional information about radiation and/or chemotherapeutic efficiency in an individual patient.

Objectives: The investigators aim to validate 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. Moreover, we aim to explore specific MRI parameters that could improve diagnostic accuracy of bone invasion and tumour relapse, as well as predict treatment response and survival in this target population.

Methods: In this trial, a validation cohort will be recruited in a prospective manner, to validate the MRI parameters that showed clinically acceptable discriminant value based on the retrospective study. The values of the selected MRI parameters will be calculated in metastatic lymph nodes of the affected group, for comparison with their values measured in the lymph nodes of a prospectively recruited control group, comprising patients who require the same standardized MRI protocol for evaluation of a Whartin tumour or pleomorphic adenoma of the parotid gland without malignant transformation, and in whom both the parotid gland lesion and the cervical lymph node are surgically removed for histological confirmation. All included patients of the 'affected group' will also undergo a preoperative positron emission tomography-computed tomography (PET-CT), according to international guidelines, and will preferably receive a multiparametric MRI at 3, 6, 12, 24, 36, 48 and 60 months post treatment as part of routine follow-up.

Details
Condition head and neck cancer, Treatment Response, Multi-parametric MRI, Multiparametric MRI, Cervical Lymph Node, Bone Invasion, Tumour Relapse, Multiparametric Magnetic Resonance Imaging, cancer of the head and neck
Clinical Study IdentifierNCT03993665
SponsorAZ Sint-Jan AV
Last Modified on2 February 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have any of these conditions: Bone Invasion or Treatment Response or head and neck cancer or Tumour Relapse or Multiparametric MRI or Cervical Lymph Node?
Do you have any of these conditions: head and neck cancer or Bone Invasion or cancer of the head and neck or Multiparametric MRI or Multiparametric Magnetic Resonance Imaging or Cervical ...?
Patients who received a pretreatment multiparametric MRI according to a standardized protocol
Histopathologically proven SCC in the HN region (affected group)
Histopathologically proven Whartin tumour or pleomorphic adenoma in the HN region without malignant transformation (control group)
Patients in whom a or multiple clearly distinguishable cervical lymph node(s) can be observed radiologically, and which can be correlated unambiguously with the pathology report

Exclusion Criteria

not fulfilling abovementioned criteria
thyroid or skin cancer
considerable artefact on MRI
previously surgery, irradiation or chemotherapy in the HN region
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