ClinicalTrials.Veeva

Menu

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

A

AZ Sint-Jan AV

Status

Active, not recruiting

Conditions

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

Study type

Observational

Funder types

Other

Identifiers

NCT03993665
B049201838067

Details and patient eligibility

About

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.

Full 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.

Enrollment

70 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

70 participants in 2 patient groups

affected
Description:
All patients with a histologically confirmed squamous cell carcinoma in the head and neck region
control
Description:
Whartin tumour or pleomorphic adenoma of the parotid gland without malignant transformation

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems