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.

October 29, 2008 updated by: Radboud University Medical Center
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

15

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Netherlands
    • Gelderland
      • Nijmegen, Gelderland, Netherlands, 6500HB
        • Recruiting
        • Radboud University Nijmegen Medical Centre
        • Principal Investigator:
          • Dominic AX Schinagl, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Radboud University Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2008

Primary Completion (Anticipated)

December 1, 2009

Study Registration Dates

First Submitted

October 29, 2008

First Submitted That Met QC Criteria

October 29, 2008

First Posted (Estimate)

October 31, 2008

Study Record Updates

Last Update Posted (Estimate)

October 31, 2008

Last Update Submitted That Met QC Criteria

October 29, 2008

Last Verified

October 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2008/060

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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