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

Head and Neck Cancer Clinical Trial

Official title:

Use of Multiparametric Magnetic Resonance Imaging in the Management of Head and Neck Cancer: a Prospective Analysis

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03993665
• Other study ID #: B049201838067
• Status: Active, not recruiting
• Start date: November 20, 2018
• Est. completion date: December 2028

Study information

• Verified date: February 2022
• Source: AZ Sint-Jan AV
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 70
• Est. completion date: December 2028
• Est. primary completion date: December 2023
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
Belgium	Division of Maxillofacial Surgery, Department of Surgery, AZ Sint-Jan Brugge-Oostende AV	Bruges

Sponsors (1)

Lead Sponsor	Collaborator
AZ Sint-Jan AV

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	discriminatory value of MRI perfusion curve between tumoural and non-tumoural cervical lymph nodes	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'	preoperative
Primary	discriminatory value of MRI ADC value between tumoural and non-tumoural cervical lymph nodes	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'	preoperative
Primary	discriminatory value of MRI D value between tumoural and non-tumoural cervical lymph nodes	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'	preoperative
Secondary	discriminatory value of perfusion curve between bone invasion and no bone invasion	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'	preoperative
Secondary	discriminatory value of predefined perfusion curve between post-therapeutic sequelae and tumour relapse	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'	follow-up until 5 years postoperative
Secondary	predictive value of the MRI parameter Ktrans for treatment outcome	predictive value of MRI parameters for treatment outcome, measured through tumoural response at therapy end based on the RECIST criteria	end of adjuvant radiochemotherapy (approx 10 weeks postoperative)
Secondary	predictive value of predefined Ktrans for overall and disease-free survival	predictive value of MRI parameters for treatment outcome, measured through tumoural response at therapy end based on the RECIST criteria	postoperative follow-up at 3, 6, 12, 24, 36,48 and 60 months