squamous cell carcinoma of the head and neck C00 C01 C02 C03 C04 C05 C06 C09 C10 C11 C12 C13 C14
Conditions
Interventions
Group 1: Established staging algorithm and clinically indicated PET/MRI examination for initial tumor staging in patients suffering from squamous cell carcinoma of the head and neck
Sponsors
Universitätsklinikum Essen, Institut für Diagnostische und Interventionelle Radiologie und Neuroradiologie
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: • Newly diagnosed locally advanced therapy-naïve T2 tumor or larger; or therapy-naïve tumor with positive N-stage, regardless of size • patient at age = 18 years • Adequate knowledge of the German language in spoken and written form • Patient is willing and able to attend the examinations or aftercare appointments • Exclusion of pregnancy • Written consent
Exclusion criteria
Exclusion criteria: • prior malignant tumor disease of the ENT area (except tumors of the skin and thyroid gland) within the last 5 years • Contraindication against MRI examination • Contraindication against MRI contrast agent • Severe renal failure (GFR 1.75 mg/dl) • Mental illness that restricts the understanding of the study • Pregnancy • Breastfeeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| change of the therapeutic managment by an additional 18F-FDG PET/MRI examination compared to the established diagnostic algorithm | — |
Secondary
| Measure | Time frame |
|---|---|
| sensitivity/specificity comparison of the established diagnostic algorithm and PET/MRI for TNM staging | — |
Countries
Germany
Contacts
Public ContactAleksandar Milosevic
Universitätsklinikum Essen, Institut für Diagnostische und Interventionelle Radiologie und Neuroradiologie
Outcome results
None listed