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Trial record 1 of 208 for:    Head and Neck PET
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Validation of High-resolution PET/CT for the Pretherapeutic Lymphnode Staging of Head/Neck Cancer

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ClinicalTrials.gov Identifier: NCT02372890
Recruitment Status : Recruiting
First Posted : February 26, 2015
Last Update Posted : July 12, 2016
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:

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 or disease
Otorhinolaryngeal Neoplasms Cancer of Head and Neck

  Show Detailed Description

Study Design

Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Validation of High-resolution PET/CT for the Pretherapeutic Lymphnode Staging of Head/Neck Cancer
Study Start Date : July 2012
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : June 2017
Groups and Cohorts

Group/Cohort
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.


Outcome Measures

Primary Outcome Measures :
  1. 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 :
  1. Diagnostic accuracy (sensitivity, specificity, accuracy, NPV und PPV) of PET/CT according to the size of lymph node metastases [ Time Frame: At baseline ]
  2. Number of patients where PET/CT results in a change of gross tumor volume (GTV) and/or dose prescription [ Time Frame: At baseline ]

Eligibility Criteria

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Posted: February 26, 2015    Key Record Dates
Last Update Posted: July 12, 2016
Last Verified: July 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