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Validation of FDG-PET Segmentation Tools for Tumor Delineation by Correlation of CT- and FDG-PET Volume Measurements With Histopathology of Nodal Metastases of Head and Neck Carcinomas.

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ClinicalTrials.gov Identifier: NCT00782691
Recruitment Status : Unknown
Verified October 2008 by Radboud University.
Recruitment status was:  Recruiting
First Posted : October 31, 2008
Last Update Posted : October 31, 2008
Sponsor:
Information provided by:
Radboud University

Brief Summary:
Various methods of FDG-PET signal segmentation will be validated by correlation of histopathologically measured tumor dimensions in lymph node dissection specimens of head-and-neck cancer patients.

Condition or disease Intervention/treatment
Head and Neck Cancer Other: CT-FDG/PET scan of the head-and-neck region

Study Type : Observational
Estimated Enrollment : 15 participants
Official Title: Validation of FDG-PET Segmentation Tools for Tumor Delineation by Correlation of CT- and FDG-PET Volume Measurements With Histopathology of Nodal Metastases of Head and Neck Carcinomas.
Study Start Date : July 2008
Estimated Primary Completion Date : December 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
Head-and-neck cancer patients.
Head-and-neck cancer patients eligible for therapeutic lymph node dissection of cervical nodes.
Other: CT-FDG/PET scan of the head-and-neck region
CT-FDG/PET scan of the head-and-neck region



Primary Outcome Measures :
  1. How accurate are the various FDG-PET segmentation tools? [ Time Frame: Measurements are performed in conjunction with the clinical pathologist directly postoperatively. ]

Biospecimen Retention:   Samples With DNA
Head-and-neck cancer patients will undergo a therapeutic lymph node dissection of the cervical nodes. This treatment is given whether the patient is enrolled in the study or not. Histological specimens of cancer patients are always stored for possible future refference in the routine clinical practice.


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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
Head-and-neck cancer patients eligible for therapeutic lymph node dissection of cervical nodes.
Criteria

Inclusion Criteria:

  • All patients with N+ squamous cell carcinoma of the head and neck, planned for neck dissection.
  • Age >18 years.

Exclusion Criteria:

  • Pregnancy.
  • Women breast feeding

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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): NCT00782691


Contacts
Contact: Dominic A.X. Schinagl, MD NL24-3614515 d.schinagl@rther.umcn.nl

Locations
Netherlands
Radboud University Nijmegen Medical Centre Recruiting
Nijmegen, Gelderland, Netherlands, 6500HB
Principal Investigator: Dominic AX Schinagl, MD         
Sponsors and Collaborators
Radboud University

Responsible Party: D.A.X. Schinagl, Radboud University Nijmegen Medical Centre
ClinicalTrials.gov Identifier: NCT00782691     History of Changes
Other Study ID Numbers: 2008/060
First Posted: October 31, 2008    Key Record Dates
Last Update Posted: October 31, 2008
Last Verified: October 2008

Keywords provided by Radboud University:
FDG-PET segmentation tools
Head-and-neck cancer
Histological validation

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