NCT00782691

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2008

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 29, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 31, 2008

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Last Updated

October 31, 2008

Status Verified

October 1, 2008

Enrollment Period

1.4 years

First QC Date

October 29, 2008

Last Update Submit

October 29, 2008

Conditions

Head and Neck Cancer

Keywords

FDG-PET segmentation toolsHead-and-neck cancerHistological validation

Outcome Measures

Primary Outcomes (1)

  • How accurate are the various FDG-PET segmentation tools?

    Measurements are performed in conjunction with the clinical pathologist directly postoperatively.

Study Arms (1)

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

Interventions

CT-FDG/PET scan of the head-and-neck regionOTHER

CT-FDG/PET scan of the head-and-neck region

Head-and-neck cancer patients.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • Pregnancy.
  • Women breast feeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Radboud University Nijmegen Medical Centre

Nijmegen, Gelderland, 6500HB, Netherlands

RECRUITING

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.

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasms

Central Study Contacts

Dominic A.X. Schinagl, MD

CONTACT

NL24-3614515d.schinagl@rther.umcn.nl

Study Design

Study Type
observational
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 29, 2008

First Posted

October 31, 2008

Study Start

July 1, 2008

Primary Completion

December 1, 2009

Last Updated

October 31, 2008

Record last verified: 2008-10

Locations

NL(1)