Validation of High-resolution PET/CT for the Pretherapeutic Lymphnode Staging of Head/Neck Cancer
In head and neck squamous cell carcinoma (HNSCC), the presence of lymph node metastases in addition to free resection margins following surgical resection of the primary tumor is an important prognostic factor, and may impact planning of surgery as well as of radiotherapy. Until now, imaging modalities including PET/CT and MRI did not allow to exclude especially small lymph node metastases.
Compared to standard whole-body PET/CT acquisition techniques, high-resolution (HR) head and neck PET/CT acquisitions promise improved detection of lymph node metastases in head and neck squamous cell carcinoma (HNSCC). This prospective study aims to determine the sensitivity and specificity of lymph node staging with HR FDG-PET/CT in HNSCC by correlating PET/CT with histopathology after neck dissection. HR PET/CT may have a relevant impact on the therapeutic concept, and the planning and dose prescription of radiotherapy.
|Otorhinolaryngeal Neoplasms Cancer of Head and Neck|
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||Validation of High-resolution PET/CT for the Pretherapeutic Lymphnode Staging of Head/Neck Cancer|
- Diagnostic accuracy (sensitivity, specificity, accuracy, NPV und PPV) of HR PET/CT in comparison to the histopathological reference standard [ Time Frame: At baseline ]
- Diagnostic accuracy (sensitivity, specificity, accuracy, NPV und PPV) of PET/CT according to the size of lymph node metastases [ Time Frame: At baseline ]
- Number of patients where PET/CT results in a change of gross tumor volume (GTV) and/or dose prescription [ Time Frame: At baseline ]
|Study Start Date:||July 2012|
|Estimated Study Completion Date:||June 2017|
|Estimated Primary Completion Date:||June 2017 (Final data collection date for primary outcome measure)|
Patients with head and neck squamous cell carcinoma with advanced primary tumor stages (cT3 or cT4), clinical suspicion of cervical lymph node metastases, cervical lymph node metastasis of unknown primary tumor (CUP) or patients with tumor recurrence scheduled for neck dissection.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT02372890
|Contact: Bernd Klaeser, MD||+41 31 635 firstname.lastname@example.org|
|Contact: Andreas Arnold, MD||+41 76 email@example.com|
|Dept. of Nuclear Medicine, Bern University Hospital, Bern||Recruiting|
|Bern, Switzerland, 3010|
|Contact: Bernd Klaeser, MD +41 31 635 3655 firstname.lastname@example.org|
|Principal Investigator: Andreas Arnold, MD|
|Principal Investigator:||Andreas Arnold, MD||University Hospital Inselspital, Berne|