Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT03993665

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Head and Neck Cancer Bone Invasion Cervical Lymph Node Head and Neck Neoplasms Multiparametric MRI Neoplasms Neoplasms by Site Treatment Response Tumour Relapse

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Division of Maxillofacial Surgery, Department of Surgery, AZ Sint-Jan Brugge-Oostende AV

Bruges, Belgium

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, 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.

Who can participate

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

Inclusion criteria

  • 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

Treatment and study plan

Primary outcomes

  1. discriminatory value of MRI perfusion curve between tumoural and non-tumoural cervical lymph nodes

    Time frame: preoperative

    MRI parameters will be considered validated if they enable 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 value between tumoural and non-tumoural cervical lymph nodes

    Time frame: preoperative

    MRI parameters will be considered validated if they enable 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 between tumoural and non-tumoural cervical lymph nodes

    Time frame: preoperative

    MRI parameters will be considered validated if they enable differentiation between a metastatic cervical lymph node and a non-tumoural lymph node, as based on the final pathology report as the 'gold standard'

Secondary outcomes

  1. discriminatory value of perfusion curve between bone invasion and no bone invasion

    Time frame: preoperative

    MRI parameters will be considered validated if they enable differentiation between tumoural bone invasion and no bone invasion, as based on the final pathology report as the 'gold standard'

  2. discriminatory value of predefined perfusion curve between post-therapeutic sequelae and tumour relapse

    Time frame: follow-up until 5 years postoperative

    MRI parameters will be considered validated if they enable differentiation between post-therapeutic sequelae and tumour relapse, as based on the final pathology report as the 'gold standard'

  3. predictive value of the MRI parameter Ktrans for treatment outcome

    Time frame: end of adjuvant radiochemotherapy (approx 10 weeks postoperative)

    predictive value of MRI parameters for treatment outcome, measured through tumoural response at therapy end based on the RECIST criteria

  4. predictive value of predefined Ktrans for overall and disease-free survival

    Time frame: postoperative follow-up at 3, 6, 12, 24, 36,48 and 60 months

    predictive value of MRI parameters for treatment outcome, measured through tumoural response at therapy end based on the RECIST criteria

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: a Prospective Analysis

Important dates

Study start
2018
Primary completion
2023
Study completion
2028
First posted
Jun 21, 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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.