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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.

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2008 by Radboud University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Radboud University
ClinicalTrials.gov Identifier:
NCT00782691
First received: October 29, 2008
Last updated: NA
Last verified: October 2008
History: No changes posted
  Purpose

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

Study Type: Observational
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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Radboud University:

Primary Outcome Measures:
  • How accurate are the various FDG-PET segmentation tools? [ Time Frame: Measurements are performed in conjunction with the clinical pathologist directly postoperatively. ] [ Designated as safety issue: No ]

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.


Estimated Enrollment: 15
Study Start Date: July 2008
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: D.A.X. Schinagl, Radboud University Nijmegen Medical Centre
ClinicalTrials.gov Identifier: NCT00782691     History of Changes
Other Study ID Numbers: 2008/060
Study First Received: October 29, 2008
Last Updated: October 29, 2008
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

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

Additional relevant MeSH terms:
Carcinoma
Head and Neck Neoplasms
Neoplasm Metastasis
Carcinoma, Squamous Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
 Neoplasms
Neoplasms by Site
Neoplastic Processes
Pathologic Processes
Neoplasms, Squamous Cell

ClinicalTrials.gov processed this record on May 23, 2013