Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Validation of High-resolution PET/CT for the Pretherapeutic Lymphnode Staging of Head/Neck Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02372890
Recruitment Status : Completed
First Posted : February 26, 2015
Last Update Posted : February 27, 2019
Sponsor:
Collaborator:
University of Bern
Information provided by (Responsible Party):
University Hospital Inselspital, Berne

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 Show detailed description

Layout table for study information
Study Type : Observational
Actual Enrollment : 153 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
Actual Primary Completion Date : December 31, 2017
Actual Study Completion Date : December 31, 2017

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.



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 ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

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


Locations
Layout table for location information
Switzerland
Dept. of Nuclear Medicine, Bern University Hospital, Bern
Bern, Switzerland, 3010
Sponsors and Collaborators
University Hospital Inselspital, Berne
University of Bern
Investigators
Layout table for investigator information
Principal Investigator: Andreas Arnold, Prof. Dr. med. University Hospital Inselspital, Berne
Layout table for additonal information
Responsible Party: University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier: NCT02372890    
Other Study ID Numbers: 277/2014
First Posted: February 26, 2015    Key Record Dates
Last Update Posted: February 27, 2019
Last Verified: February 2019
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:
Layout table for MeSH terms
Head and Neck Neoplasms
Neoplasms
Neoplasms by Site