Validation of FDG-PET Segmentation Tools for Tumor Deline... | NCT00782691

Status Module

Record Verification Date

Oct 2008

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2008

Primary Completion Date

Dec 2009Estimated

Completion Date

Not provided

First Submitted Date

Oct 29, 2008

First Submission Date that Met QC Criteria

Oct 29, 2008

First Posted Date

Oct 31, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 29, 2008

Last Update Posted Date

Oct 31, 2008Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

No data available

No data is available for this block.

Biospecimen

Retention

Enrollment

15Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
CT-FDG/PET scan of the head-and-neck region	Other	CT-FDG/PET scan of the head-and-neck region	Head-and-neck cancer patients.

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Dominic A.X. Schinagl, MD	Contact	NL24-3614515		d.schinagl@rther.umcn.nl

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Radboud University Nijmegen Medical Centre	Recruiting	Nijmegen	Gelderland	6500HB	Netherlands

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

No data available

No data is available for this block.

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.

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms