PET/MRI for initial staging of squamous cell carcinoma of the head and neck
- Conditions
- squamous cell carcinoma of the head and neckC00C01C02C03C04C05C06C09C10
- Registration Number
- DRKS00023750
- Lead Sponsor
- niversitätsklinikum Essen, Institut für Diagnostische und Interventionelle Radiologie und Neuroradiologie
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 140
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
• 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 <30 mg/dl; serum creatinine >1.75 mg/dl)
• Mental illness that restricts the understanding of the study
• Pregnancy
• Breastfeeding
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method change of the therapeutic managment by an additional 18F-FDG PET/MRI examination compared to the established diagnostic algorithm
- Secondary Outcome Measures
Name Time Method sensitivity/specificity comparison of the established diagnostic algorithm and PET/MRI for TNM staging