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
This study investigates the diagnostic value of PET/MRI for cervical lymph node metastases from head and neck squamous cell carcinomas.
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 |
Country | Name | City | State |
---|---|---|---|
Denmark | Department of ORL - Head & Neck Surgery and Audiology, Odense University Hospital | Odense |
Lead Sponsor | Collaborator |
---|---|
Odense University Hospital | University of Southern Denmark |
Denmark,
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 |
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