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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.

Primary Purpose

Head and Neck Cancer

Status
Unknown status
Phase
Locations
Netherlands
Study Type
Observational
Intervention
CT-FDG/PET scan of the head-and-neck region
Sponsored by
Radboud University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an observational trial for Head and Neck Cancer focused on measuring FDG-PET segmentation tools, Head-and-neck cancer, Histological validation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Radboud University Nijmegen Medical CentreRecruiting

Arms of the Study

Arm 1

Arm Type

Arm Label

Head-and-neck cancer patients.

Arm Description

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

Outcomes

Primary Outcome Measures

How accurate are the various FDG-PET segmentation tools?

Secondary Outcome Measures

Full Information

First Posted
October 29, 2008
Last Updated
October 29, 2008
Sponsor
Radboud University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00782691
Brief 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.
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 Type
Observational

2. Study Status

Record Verification Date
October 2008
Overall Recruitment Status
Unknown status
Study Start Date
July 2008 (undefined)
Primary Completion Date
December 2009 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Radboud University Medical Center

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer
Keywords
FDG-PET segmentation tools, Head-and-neck cancer, Histological validation

7. Study Design

Enrollment
15 (Anticipated)
Biospecimen Retention
Samples With DNA
Biospecimen Description
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.

8. Arms, Groups, and Interventions

Arm Title
Head-and-neck cancer patients.
Arm Description
Head-and-neck cancer patients eligible for therapeutic lymph node dissection of cervical nodes.
Intervention Type
Other
Intervention Name(s)
CT-FDG/PET scan of the head-and-neck region
Intervention Description
CT-FDG/PET scan of the head-and-neck region
Primary Outcome Measure Information:
Title
How accurate are the various FDG-PET segmentation tools?
Time Frame
Measurements are performed in conjunction with the clinical pathologist directly postoperatively.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Study Population Description
Head-and-neck cancer patients eligible for therapeutic lymph node dissection of cervical nodes.
Sampling Method
Non-Probability Sample
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dominic A.X. Schinagl, MD
Phone
NL24-3614515
Email
d.schinagl@rther.umcn.nl
Facility Information:
Facility Name
Radboud University Nijmegen Medical Centre
City
Nijmegen
State/Province
Gelderland
ZIP/Postal Code
6500HB
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dominic AX Schinagl, MD

12. IPD Sharing Statement

Learn more about this trial

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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