The Diagnostic Value of PET/MRI in Head and Neck Cancer
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|ClinicalTrials.gov Identifier: NCT04117139|
Recruitment Status : Recruiting
First Posted : October 7, 2019
Last Update Posted : October 8, 2019
|Condition or disease||Intervention/treatment||Phase|
|Squamous Cell Carcinoma of Head and Neck Head and Neck Neoplasms Lymph Node Metastases||Diagnostic Test: PET/MRI||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||142 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||October 1, 2019|
|Estimated Primary Completion Date :||September 30, 2021|
|Estimated Study Completion Date :||September 30, 2022|
In addition to other standard imaging modalities in the fast track cancer program, included patients will have a PET/MRI done.
Diagnostic Test: PET/MRI
A PET/MRI of the Head and Neck region is done for all patients included in the project.
- Diagnostic Accuracy of PET/MRI for Malignancy in Regional Lymph Nodes [ Time Frame: 7-10 days ]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
- Diagnostic Accuracy of PET/MRI for Extracapsular Lymph Node Spread [ Time Frame: 7-10 days ]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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04117139
|Contact: Christian Godballe, Professor||+45 6541 email@example.com|
|Contact: Chadi N. Abdel-Halim, M.D.||firstname.lastname@example.org|
|Department of ORL - Head & Neck Surgery and Audiology, Odense University Hospital||Recruiting|
|Odense, Denmark, 5000|
|Contact: Chadi N. Abdel-Halim, M.D.|
|Principal Investigator:||Chadi N. Abdel-Halim, M.D.||Odense University Hospital|