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

NCT ID: NCT03993665

Last Updated: 2022-02-24

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 70 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-11-20
• Study Completion Date: 2028-12-31

Brief 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.

Detailed 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.

Conditions

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

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

affected

All patients with a histologically confirmed squamous cell carcinoma in the head and neck region

No interventions assigned to this group

control

Whartin tumour or pleomorphic adenoma of the parotid gland without malignant transformation

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AZ Sint-Jan AV

OTHER

Sponsor Role: lead

Responsible Party

Johan Abeloos

head of department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Johan Abeloos, MD

Role: PRINCIPAL_INVESTIGATOR

AZ Sint-Lucas Brugge

Locations

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

Bruges, , Belgium

Countries

Belgium

Other Identifiers

B049201838067

Identifier Type: -

Identifier Source: org_study_id