The Diagnostic Value of PET/MRI in Head and Neck Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

142 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-01

Study Completion Date

2022-09-30

Brief Summary

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This study investigates the diagnostic value of PET/MRI for cervical lymph node metastases from head and neck squamous cell carcinomas.

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Detailed Description

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The Danish fast-track cancer program standardizes the work-up of patients suspected of head and neck cancer. Currently, the guidelines recommend head and neck magnetic resonance imaging (MRI) as the standard imaging modality for assessment of the primary tumor site and potential nodal metastases. However, recent studies have shown advantages in the use of 18F-FDG-PET (PET) combined with computed tomography (CT) due to its superiority in detecting metastases and synchronous cancers.

During the last couple of years PET/MRI has been introduced. MRI is known to provide the highest anatomic detail in the head and neck region, and preliminary studies show promising results. However, the evidence is still very sparse.

The purpose of the project is to investigate the diagnostic value of PET/MRI in patients with head and neck squamous cell carcinoma. The hypothesis is that PET/MRI provides a more precise diagnosis of regional lymph node metastases, and thus, make the surgical treatment of the neck more accurate and less invasive resulting in reduced morbidity.

The project is designed as a prospective cohort study based on paired data with head-to-head comparison of CT, MRI, PET/CT and PET/MRI. Patients will be included from the head and neck cancer fast-track program at the Center of Head and Neck Cancer, Odense University Hospital (OUH).

Included patients will be offered PET/MRI in addition to the conventional fast-track imaging. The description of the images will be made blinded. When a neck dissection of the lymph nodes is made, the lymph nodes will be separated in defined regions. The diagnostic accuracy of the individual imaging modalities is assessed for each neck level with histology as standard reference.

Conditions

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Squamous Cell Carcinoma of Head and Neck Head and Neck Neoplasms Lymph Node Metastases

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Study Group

In addition to other standard imaging modalities in the fast track cancer program, included patients will have a PET/MRI done.

Group Type OTHER

PET/MRI

Intervention Type DIAGNOSTIC_TEST

A PET/MRI of the Head and Neck region is done for all patients included in the project.

Interventions

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PET/MRI

A PET/MRI of the Head and Neck region is done for all patients included in the project.

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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18F-FDG-PET/MRI FDG-PET/MRI PET/MR PET-MR Positron-Emission-Tomography/Magnetic Resonance Imaging

Eligibility Criteria

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Inclusion Criteria

Patients either suspected of or with histologically verified:

* Relapse of head and neck squamous cell cancer with involvement of regional lymph node(s)
* Cervical lymph node metastasis with unknown primary tumor site
* Oral cavity squamous cell carcinoma
* Oropharyngeal squamous cell cancer planned for trans oral robotic surgery

Exclusion Criteria

* Patients who cannot have a PET/MRI performed for different reasons (allergy, claustrophobia, medical implants)
* Patients who had surgery, infection or other inflammatory inducing conditions on the neck within the last 8 weeks

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No