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

Head and Neck Neoplasms Clinical Trial

Official title:

The Diagnostic Value of 18F-2-fluoro-2-deoxy-D-glucose Fluorodeoxyglucose-Positron-Emission-Tomography/Magnetic-Resonance Imaging (PET/MRI) for Cervical Lymph Node Metastasis in Head and Neck Squamous Cell Carcinoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04117139
• Other study ID #: HNC PET/MRI
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2019
• Est. completion date: September 30, 2022

Study information

• Verified date: October 2019
• Source: Odense University Hospital
• Contact: Christian Godballe, Professor
• Phone: +45 6541 2800
• Email: christian.godballe[@]rsyd.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 142
• Est. completion date: September 30, 2022
• Est. primary completion date: September 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Head and Neck Neoplasms
• Lymph Node Metastases
• Neoplasm Metastasis
• Squamous Cell Carcinoma of Head and Neck

Intervention

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

Locations

Country	Name	City	State
Denmark	Department of ORL - Head & Neck Surgery and Audiology, Odense University Hospital	Odense

Sponsors (2)

Lead Sponsor	Collaborator
Odense University Hospital	University of Southern Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic Accuracy of PET/MRI for Malignancy in Regional Lymph Nodes	PET/MRI scans are compared to histology as the golden standard to determine the diagnostic accuracy of PET/MRI for malignancy in regional lymph nodes	7-10 days
Secondary	Diagnostic Accuracy of PET/MRI for Extracapsular Lymph Node Spread	PET/MRI scans are compared to histology as the golden standard to determine the diagnostic accuracy of PET/MRI for extracapsular spread in regional lymph nodes	7-10 days

External Links

•   Description of the PET/MRI facilities at Odense University Hospital