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Trial record 1 of 199 for:    Head and Neck PET
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Validation of High-resolution PET/CT for the Pretherapeutic Lymphnode Staging of Head/Neck Cancer

This study is currently recruiting participants.
See Contacts and Locations
Verified July 2016 by University Hospital Inselspital, Berne
Sponsor:
Collaborator:
University of Bern
Information provided by (Responsible Party):
University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier:
NCT02372890
First received: January 19, 2015
Last updated: July 11, 2016
Last verified: July 2016
  Purpose

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.


Condition
Otorhinolaryngeal Neoplasms Cancer of Head and Neck

Study Type: Observational
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

Further study details as provided by University Hospital Inselspital, Berne:

Primary Outcome Measures:
  • Diagnostic accuracy (sensitivity, specificity, accuracy, NPV und PPV) of HR PET/CT in comparison to the histopathological reference standard [ Time Frame: At baseline ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 150
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)
Groups/Cohorts
All patients
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with head and neck squamous cell carcinoma undergoing routine PET/CT staging or restaging and sheduled for neck dissection according to the decision of the interdisziplinary tumor board.
Criteria

Inclusion Criteria:

  • Head and neck squamous cell carcinoma (HNSCC), fulfilling one or more of the following criteria:

    • Advanced primary tumor stage (cT3 or cT4)
    • Clinical suspicion of neck lymph node metastases
    • Cervical lymph node metastases of unknown primary tumor (CUP)
    • Tumor recurrence
  • Mature adult
  • Written informed consent

Exclusion Criteria:

  • Inoperability
  • Histologically verified cervical lymph node metastases of other tumors
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02372890

Contacts
Contact: Bernd Klaeser, MD +41 31 635 3655 bernd.klaeser@insel.ch
Contact: Andreas Arnold, MD +41 76 3730005 andreas.arnold@insel.ch

Locations
Switzerland
Dept. of Nuclear Medicine, Bern University Hospital, Bern Recruiting
Bern, Switzerland, 3010
Contact: Bernd Klaeser, MD    +41 31 635 3655    bernd.klaeser@insel.ch   
Principal Investigator: Andreas Arnold, MD         
Sponsors and Collaborators
University Hospital Inselspital, Berne
University of Bern
Investigators
Principal Investigator: Andreas Arnold, MD University Hospital Inselspital, Berne
  More Information

Responsible Party: University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier: NCT02372890     History of Changes
Other Study ID Numbers: 277/2014
Study First Received: January 19, 2015
Last Updated: July 11, 2016

Keywords provided by University Hospital Inselspital, Berne:
Otorhinolaryngeal Neoplasms
Cancer of Head and Neck
Head and Neck Squamous Cell Carcinoma
Positron Emission Tomography
PET/CT
FDG

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms

ClinicalTrials.gov processed this record on September 19, 2017