Head and Neck CancerNCT00782691
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.
An observational study of Head and Neck Cancer, run by Radboud University Medical Center at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- CT-FDG/PET scan of the head-and-neck region
- How many people
- 15 participants
- Where
- 1 siteNetherlands
- Study dates
- Jul 2008to Dec 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Head-and-neck cancer patients eligible for therapeutic lymph node dissection of cervical nodes.
Who may be able to join
- All patients with N+ squamous cell carcinoma of the head and neck, planned for neck dissection.
- Age >18 years.
Who cannot join
- Pregnancy.
- Women breast feeding
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Radboud University Nijmegen Medical Centre
Nijmegen, Gelderland, 6500HB
Dominic AX Schinagl, MD
About this study
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.
- Conditions
- Head and Neck Cancer
- Being tested
- CT-FDG/PET scan of the head-and-neck region
- Keywords
- FDG-PET segmentation tools, Head-and-neck cancer, Histological validation
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT-FDG/PET scan of the head-and-neck regionOther
CT-FDG/PET scan of the head-and-neck region
| Study group | Role | What they receive |
|---|---|---|
| Head-and-neck cancer patients. | Head-and-neck cancer patients eligible for therapeutic lymph node dissection of cervical nodes. Receives: Other: CT-FDG/PET scan of the head-and-neck region |
What is being measured
The primary outcome is the main question the study is designed to answer.
How accurate are the various FDG-PET segmentation tools?
Measured: Measurements are performed in conjunction with the clinical pathologist directly postoperatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2008 (estimated)
- Study startJul 2008
- Primary completionDec 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00782691
- Sponsor's protocol ID
- 2008/060
- Status last verified
- Oct 2008
- First submitted
- 29 Oct 2008
- Last updated
- 31 Oct 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00782691
- Acronym / sponsor ID
- 2008/060
- Conditions
- Head and Neck Cancer
- Keywords
- FDG-PET segmentation tools, Head-and-neck cancer, Histological validation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- Jul 2008
- Primary completion
- Dec 2009 (estimated)
- First posted
- 31 Oct 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Head-and-neck cancer patients. | – | Other: CT-FDG/PET scan of the head-and-neck regionHead-and-neck cancer patients eligible for therapeutic lymph node dissection of cervical nodes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Head-and-neck cancer patients eligible for therapeutic lymph node dissection of cervical nodes.
Key inclusion criteria (2 listed)
- All patients with N+ squamous cell carcinoma of the head and neck, planned for neck dissection.
- Age >18 years.
Key exclusion criteria (2 listed)
- Pregnancy.
- Women breast feeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CT-FDG/PET scan of the head-and-neck regionCT-FDG/PET scan of the head-and-neck region | Other | Head-and-neck cancer patients. |
Primary outcome
How accurate are the various FDG-PET segmentation tools?
Time frame: Measurements are performed in conjunction with the clinical pathologist directly postoperatively.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Head and Neck Cancer, run by Radboud University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Oct 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dominic A.X. Schinagl, MD (NL24-3614515, d.schinagl@rther.umcn.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
How accurate are the various FDG-PET segmentation tools? (time frame: Measurements are performed in conjunction with the clinical pathologist directly postoperatively.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2008.